Identity
- Trade Name
- INTRAFIX FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- INTRAFIX Tapered Screw 6-8mm x 30mm FDA UDI
- Model / Reference
- 254602 FDA UDI
- Description
- INTRAFIX Tapered Screw 6-8mm x 30mm FDA UDI
Identifiers
- Catalog Number
- 254602 FDA UDI
- Primary DI / UDI-DI
- 10886705013081 FDA UDI
- FDA Product Code
- MBI FDA UDIJDR FDA UDIMAI FDA UDIHTY FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable 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
MR Safe FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Intrafix by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
- OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
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.
- 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.
- MILAGRO — DePuy Mitek, Inc.
K983560 also covers:
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
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 9519b7b9-af8d-4007-be2b-a44b2347e4c4 36 fields · synced May 31, 2026