Identity
- Trade Name
- PORK K-15 FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- POROUS ROUND PATELLA SZ 26MM FDA UDI
- Model / Reference
- 74025462 FDA UDI
- Description
- POROUS ROUND PATELLA SZ 26MM FDA UDI
Identifiers
- Catalog Number
- 74025462 FDA UDI
- Primary DI / UDI-DI
- 00885556769522 FDA UDI
- 510(k) Number
- K211221 FDA UDI
- FDA Product Code
- MBH FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyethylene patella prosthesis
Pork K-15 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polyethylene patella prosthesis.
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Cleared under the same submission
K211221 also covers:
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, Inc.
- K-15 PORK — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 57032c0e-18d5-4965-be01-350498c9a9bf 36 fields · synced Jun 8, 2026