Identity
- Trade Name
- TRAY MOD 78 FDA UDI
- Generic Name
- Coated knee tibia prosthesis FDA UDI
- Model / Reference
- 10329 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209103290 FDA UDI
- 510(k) Number
- K904448 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
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 knee tibia prosthesis
Tray Mod 78 by Biopro, Inc. — 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
K904448 also covers:
- CORTICAL BONE SCREW 4.5/40MM — BIOPRO, INC.
- CORTICAL BONE SCREW 4.5/55MM — BIOPRO, INC.
- INSERT CC 26 X 48 — BIOPRO, INC.
- INSERT CC 26 X 53 — BIOPRO, INC.
- INSERT TOTAL 10X70 — BIOPRO, INC.
- INSERT TOTAL 10X78 — BIOPRO, INC.
- INSERT TOTAL 10X86 — BIOPRO, INC.
- INSERT TOTAL 12X62 — BIOPRO, INC.
- INSERT TOTAL 12X74 — BIOPRO, INC.
- INSERT TOTAL 13X70 — BIOPRO, INC.
- INSERT TOTAL 13X74 — BIOPRO, INC.
- INSERT TOTAL 13X78 — 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 2c58c445-bf2e-44b3-af24-569298fac107 33 fields · synced Jun 8, 2026