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<eudamedExport entity="devices">
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    <udiDi>00810004723542</udiDi>
    <basicUdiDi>B-00810004723542</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 11mm or 13mm x 25 mm, 6 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS20623X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:09.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723535</udiDi>
    <basicUdiDi>B-00810004723535</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 10mm or 12mm x 25 mm, 6 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS10623X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:08.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723528</udiDi>
    <basicUdiDi>B-00810004723528</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 11mm or 14mm x 25 mm, 0 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS40023X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:07.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723511</udiDi>
    <basicUdiDi>B-00810004723511</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 10mm or 13mm x 25 mm, 0 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS30023X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:03.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723504</udiDi>
    <basicUdiDi>B-00810004723504</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 9mm or 12mm x 25 mm, 0 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS20023X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:02.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723498</udiDi>
    <basicUdiDi>B-00810004723498</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shim, 8mm or 11mm x 25 mm, 0 degree, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPAS10023X</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:02.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723481</udiDi>
    <basicUdiDi>B-00810004723481</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shell, Tall 25 mm, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPACT0023SB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:40:01.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723474</udiDi>
    <basicUdiDi>B-00810004723474</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Shell, Short 25 mm, FlareHawk 9</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09070199</emdnCode>
    <emdnDescription>SPINAL FUSION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FHPACS0023SB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:57.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723443</udiDi>
    <basicUdiDi>B-00810004723443</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Micro Guide Pin</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>FHGP23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:56.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723436</udiDi>
    <basicUdiDi>B-00810004723436</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Micro 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-00317</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:55.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723429</udiDi>
    <basicUdiDi>B-00810004723429</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tall Impactor</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-00547</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:54.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723412</udiDi>
    <basicUdiDi>B-00810004723412</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Short Impactor</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-00546</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:50.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723405</udiDi>
    <basicUdiDi>B-00810004723405</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>16 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-00697</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:50.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723399</udiDi>
    <basicUdiDi>B-00810004723399</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>15 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-00696</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:49.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723382</udiDi>
    <basicUdiDi>B-00810004723382</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>14 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-00695</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:48.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723375</udiDi>
    <basicUdiDi>B-00810004723375</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>13 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-00694</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:44.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723368</udiDi>
    <basicUdiDi>B-00810004723368</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>12 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-00693</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:43.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723351</udiDi>
    <basicUdiDi>B-00810004723351</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>11 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-00692</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:42.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723344</udiDi>
    <basicUdiDi>B-00810004723344</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>10 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-00691</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:42.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004723337</udiDi>
    <basicUdiDi>B-00810004723337</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>9 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-00690</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:39:38.164Z</lastUpdated>
  </row>
</eudamedExport>