Identity
- Trade Name
- GMK Primary Total Knee System FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Device Name
- STD Cemented Femur #1 R TiNbN coated FDA UDI
- Model / Reference
- 02.07.2701R FDA UDI
- Description
- STD Cemented Femur #1 R TiNbN coated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030821639 FDA UDI
- 510(k) Number
- K202684 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Coated knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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: Coated knee femur prosthesis
GMK Primary Total Knee System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated knee femur prosthesis.
- PHYSICA POROUS PS — Limacorporate · Class II
- PHYSICA POROUS KR — Limacorporate · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
- Persona® PPS® — Zimmer, Inc. · Class II
- Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
- SIGMA — DEPUY (IRELAND) · Class II
- APEX PS Knee — OMNIlife science, Inc. · Class II
Cleared under the same submission
K202684 also covers:
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
- GMK Primary Total Knee System — Medacta International
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
- Medacta International
Sources (1)
- FDA UDI 066b47eb-b91f-4914-9c6c-de91f1928b63 34 fields · synced May 30, 2026