Identity
- Trade Name
- UNI LL/RM LG FDA UDI
- Generic Name
- Coated unicondylar knee femur prosthesis FDA UDI
- Model / Reference
- 10297 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209102970 FDA UDI
- 510(k) Number
- K890044 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Coated unicondylar knee femur prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3530 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coated unicondylar knee femur prosthesis
Uni Ll/Rm Lg by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated unicondylar knee femur prosthesis.
- MOTO Partial Knee System — Medacta International · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- Unicondylar Sled Prosthesis — WALDEMAR LINK GmbH & Co. KG · Class II
- MOTO Partial Knee System — Medacta International · Class II
- MOTO Partial Knee System — Medacta International · Class II
- MOTO Partial Knee System — Medacta International · Class II
- MOTO Partial Knee System — Medacta International · Class II
- MOTO Partial Knee System — Medacta International · Class II
Cleared under the same submission
K890044 also covers:
- INSERT UN-I XLG 11.5 — BIOPRO, INC.
- INSERT UNI COMP LG 10.0 — BIOPRO, INC.
- INSERT UNI COMP LG 11.5 — BIOPRO, INC.
- INSERT UNI COMP LG 8.5 — BIOPRO, INC.
- INSERT UNI COMP MD 10.0 — BIOPRO, INC.
- INSERT UNI COMP MD 11.5 — BIOPRO, INC.
- INSERT UNI COMP MD 8.5 — BIOPRO, INC.
- INSERT UNI COMP SM 10.0 — BIOPRO, INC.
- INSERT UNI COMP SM 11.5 — BIOPRO, INC.
- INSERT UNI COMP SM 8.5 — BIOPRO, INC.
- INSERT UNI COMP XLG 10.0 — BIOPRO, INC.
- INSERT UNI COMP XLG 11.5 — BIOPRO, 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
- Biopro, Inc.
Sources (1)
- FDA UDI 71f55b52-3347-40a0-aa6c-9ce50d040d26 33 fields · synced Jun 8, 2026