Identity
- Trade Name
- INSERT CC 26 X 53 FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Model / Reference
- 11798 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209117980 FDA UDI
- 510(k) Number
- K904448 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Polyethylene patella 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: Polyethylene patella prosthesis
Insert Cc 26 X 53 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene patella prosthesis.
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- LOSPA Total Knee System — Corentec Co., Ltd · Class II
- ADVANCE® — MicroPort Orthopedics Inc. · Class II
- Unity Total Knee System — CORIN LTD · Class II
- Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II
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 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.
- INSERT TOTAL 14X66 — 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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI e4604c9a-4d96-4701-9ff7-745c56796cc2 33 fields · synced May 30, 2026