Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Device Name
- BASEPLATE,TIBIAL, STEMMED, POROUS SIZE8 L W/NS BEADS FDA UDI
- Model / Reference
- 311-02-108 FDA UDI
- Description
- BASEPLATE,TIBIAL, STEMMED, POROUS SIZE8 L W/NS BEADS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912113717 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Coated knee tibia 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
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 tibia 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 tibia prosthesis.
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Natural-Knee® — Zimmer, Inc. · Class II
- Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
- OMNI Knee — OMNIlife science, Inc. · Class II
- Columbus® CR/PS — AESCULAP, INC. · Class II
- ADVANTIM® — MicroPort Orthopedics Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class I
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.
K970031 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Encore Medical, L.p.
Sources (1)
- FDA UDI 68133dde-f278-4714-b955-2e3a5b7c1d80 34 fields · synced May 30, 2026