Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Coated knee femur prosthesis FDA UDI
- Device Name
- FEMUR, POROUS COATED, W/NS BEADS, SIZE5, LT FDA UDI
- Model / Reference
- 211-02-105 FDA UDI
- Description
- FEMUR, POROUS COATED, W/NS BEADS, SIZE5, LT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912110044 FDA UDI
- 510(k) Number
- K923277 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
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Cruciate-retaining total knee prosthesisCoated knee femur prosthesis
Djo Surgical by Encore Medical, L.p. — 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
- GMK Primary Total Knee System — Medacta International · 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
Cleared under the same submission
K923277 also covers:
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
- DJO SURGICAL — ENCORE MEDICAL, L.P.
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 |
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Manufacturer
- Manufacturer
- Encore Medical, L.p.
Sources (1)
- FDA UDI 99646380-5b98-4c9b-92d3-ee9b84473bf6 34 fields · synced Jun 6, 2026