Identity
- Trade Name
- INTRAFIX FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm FDA UDI
- Model / Reference
- 254684 FDA UDI
- Description
- FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm FDA UDI
Identifiers
- Catalog Number
- 254684 FDA UDI
- Primary DI / UDI-DI
- 10886705013654 FDA UDI
- FDA Product Code
- HWC FDA UDIMBI FDA UDIMAI FDA UDIJDR FDA UDIHTY FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Intrafix by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- Arthrex® — Arthrex, Inc. · Class II
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- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K063577 also covers:
K150209 also covers:
- BIOKNOTLESS ETHIBOND — DePuy Mitek, Inc.
- BIOKNOTLESS PANACRYL ETHIBOND — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- LUPINE — DePuy Mitek, Inc.
- LUPINE — DePuy Mitek, Inc.
- LUPINE ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International Sàrl
Sources (1)
- FDA UDI 9b3fd3c2-48a6-4dee-a50c-a45417dc2c1b 36 fields · synced May 30, 2026