<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810004728745</udiDi>
    <basicUdiDi>B-00810004728745</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Thin Shaft Osteotome</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00459</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:21:53.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004727991</udiDi>
    <basicUdiDi>B-00810004727991</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>½” Straight Osteotome</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:20:28.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111342015</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Cottle Chisel 18 cm - 7" Blade Width 6.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-660-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:39:02.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111342831</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Rubin Osteotome 18.5 cm - 7 1/4" Blade Width 16.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RH-636-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:39:02.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345597</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 3 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345603</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 4 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-04</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345610</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 6 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345627</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 8 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-08</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345634</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 10 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345641</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Mini-Lambotte Bone Osteotome Curved 17 cm - 6 3/4" Blade Width 12 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-323-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345658</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Lambotte Bone Osteotome Curved 24 cm - 9 1/2" Blade Width 6 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-325-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345665</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Stille Bone Osteotome Curved 20 cm - 8" Blade Width 12 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-329-12 C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345672</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Stille Bone Osteotome Curved 20 cm - 8" Blade Width 20 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-329-20 C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345702</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Smith-Peterson Bone Osteotome 20.5 cm - 8" Blade Width 10 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-332-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345719</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Smith-Peterson Bone Osteotome Curved 20.5 cm - 8" Blade Width 12 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-333-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345764</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Hibbs Bone Osteotome 24.5 cm - 9 3/4" Blade Width 16 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-340-16</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345771</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Hibbs Bone Osteotome Curved 24.5 cm - 9 3/4" Blade Width 9 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-341-09</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345825</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>FiberGrip Mini-Lexer Bone Osteotome 18.5 cm - 7 1/4" Blade Width 2 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-360-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345832</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>FiberGrip Lexer Bone Chisel 20 cm - 8" Blade Width 25 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-364-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111345849</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>FiberGrip Lexer Bone Chisel 20 cm - 8" Blade Width 30 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-364-30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T23:38:57.365Z</lastUpdated>
  </row>
</eudamedExport>