<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810004722309</udiDi>
    <basicUdiDi>B-00810004722309</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shell Removal Tool, FH7</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>L091106</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00255</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:46.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723313</udiDi>
    <basicUdiDi>B-00810004723313</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>7 mm x 29 mm, 0 Degree Distractor</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>L0920</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-00688</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:46.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723214</udiDi>
    <basicUdiDi>B-00810004723214</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>FH9 Insertion Instrument</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>L091106</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00316</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:45.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004722101</udiDi>
    <basicUdiDi>B-00810004722101</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Pituitary, Straight 3mm, FH7</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>L091307</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RONGEURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00147</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:25.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004722088</udiDi>
    <basicUdiDi>B-00810004722088</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Obturator Impactor, Tall</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>L0920</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00154</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:20.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004722071</udiDi>
    <basicUdiDi>B-00810004722071</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Obturator Impactor, Short</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>L0920</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY DISTRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00153</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:19.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004721999</udiDi>
    <basicUdiDi>B-00810004721999</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Articulating Curette, FH7</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>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00149</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:13.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004721890</udiDi>
    <basicUdiDi>B-00810004721890</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Repeater Bone Funnel</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>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00133</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:10.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004721869</udiDi>
    <basicUdiDi>B-00810004721869</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Bone Funnel</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>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:05.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004721838</udiDi>
    <basicUdiDi>B-00810004721838</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Insertion Instrument, FlareHawk 7</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>L091106</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00120</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:05.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004721814</udiDi>
    <basicUdiDi>B-00810004721814</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Guide Pin, FlareHawk 7</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>L091106</emdnCode>
    <emdnDescription>INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHTPGP1A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:17:03.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701037305829</udiDi>
    <basicUdiDi>37010373RETROVRPG</basicUdiDi>
    <tradeName>03701037305829</tradeName>
    <deviceName>RETROVERSION STEM</deviceName>
    <manufacturerName>FX Shoulder Solutions</manufacturerName>
    <manufacturerSrn>FR-MF-000000465</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>903-0004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T03:35:54.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701037307182</udiDi>
    <basicUdiDi>37010373HMAIMGDAB</basicUdiDi>
    <tradeName>03701037307182</tradeName>
    <deviceName>AIMING GUIDE SCREW</deviceName>
    <manufacturerName>FX Shoulder Solutions</manufacturerName>
    <manufacturerSrn>FR-MF-000000465</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-0056</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T03:35:54.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701037306161</udiDi>
    <basicUdiDi>37010373HANDLE6G</basicUdiDi>
    <tradeName>03701037306161</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FX Shoulder Solutions</manufacturerName>
    <manufacturerSrn>FR-MF-000000465</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>903-0076</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T03:35:54.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701037305591</udiDi>
    <basicUdiDi>37010373HANDLE6G</basicUdiDi>
    <tradeName>03701037305591</tradeName>
    <deviceName>HANDLE</deviceName>
    <manufacturerName>FX Shoulder Solutions</manufacturerName>
    <manufacturerSrn>FR-MF-000000465</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902-0004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T03:35:54.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701037303672</udiDi>
    <basicUdiDi>37010373TRIAADEJ</basicUdiDi>
    <tradeName>03701037303672</tradeName>
    <deviceName>TRIAL ADAPTER</deviceName>
    <manufacturerName>FX Shoulder Solutions</manufacturerName>
    <manufacturerSrn>FR-MF-000000465</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L091199</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902-0010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T03:35:54.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D1067521190000*</udiDi>
    <basicUdiDi>++D106ORTHOPEDICSRB</basicUdiDi>
    <tradeName>*+D1067521190000*</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABI Enterprises</manufacturerName>
    <manufacturerSrn>PK-MF-000035328</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75-2119-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:38:32.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D1067521190101*</udiDi>
    <basicUdiDi>++D106ORTHOPEDICSRB</basicUdiDi>
    <tradeName>*+D1067521190101*</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABI Enterprises</manufacturerName>
    <manufacturerSrn>PK-MF-000035328</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75-2119-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:38:32.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D1067590510002*</udiDi>
    <basicUdiDi>++D106ORTHOPEDICSRB</basicUdiDi>
    <tradeName>*+D1067590510002*</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABI Enterprises</manufacturerName>
    <manufacturerSrn>PK-MF-000035328</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75-9051-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:38:32.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D1067590510204*</udiDi>
    <basicUdiDi>++D106ORTHOPEDICSRB</basicUdiDi>
    <tradeName>*+D1067590510204*</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ABI Enterprises</manufacturerName>
    <manufacturerSrn>PK-MF-000035328</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>75-9051-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:38:32.402Z</lastUpdated>
  </row>
</eudamedExport>