Identity
- Trade Name
- INSERT UNI COMP SM 11.5 FDA UDI
- Generic Name
- Unicondylar knee insert FDA UDI
- Model / Reference
- 14136 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209141360 FDA UDI
- 510(k) Number
- K890044 FDA UDI
- FDA Product Code
- HRY FDA UDI
- GMDN Term
- Unicondylar knee insert 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: Unicondylar knee insert
Insert Uni Comp Sm 11.5 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Unicondylar knee insert.
- Alliant Biotech — Medisurge · Class II
- Vivacit-E® — Zimmer, Inc. · Class II
- Unicondylar Knee System — GLOBUS MEDICAL, INC. · Class II
- MOTO Partial Knee System - Medial — Medacta International · Class II
- GENESIS — Smith & Nephew, Inc. · Class II
- JOURNEY — Smith & Nephew, Inc. · Class II
- GMK Uni — Medacta International · Class II
- SIGMA — DEPUY (IRELAND) · 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 8.5 — BIOPRO, INC.
- INSERT UNI COMP XLG 10.0 — BIOPRO, INC.
- INSERT UNI COMP XLG 11.5 — BIOPRO, INC.
- INSERT UNI COMP XLG 8.5 — 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 f11a52c2-fd21-40d1-bd6c-c7b9ca69e3e6 33 fields · synced May 31, 2026