Identity
- Trade Name
- Patellar Button FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Device Name
- Patellar Button 30/45 FDA UDI
- Model / Reference
- 30/45 FDA UDI
- Description
- Patellar Button 30/45 FDA UDI
Identifiers
- Catalog Number
- 22-04-03045 FDA UDI
- Primary DI / UDI-DI
- B0462204030450 FDA UDI
- 510(k) Number
- K080199 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
Patellar Button by Signal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080199 also covers:
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
- Alliant Biotech — Medisurge
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
- Signal Medical Corp.
Sources (1)
- FDA UDI 0e56df0b-1bea-4202-a95d-b7ea34eec42f 36 fields · synced May 30, 2026