Identity
- Trade Name
- Patellar Adjustment Socket FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Model / Reference
- D20 FDA UDI
Identifiers
- Catalog Number
- 63420PF FDA UDI
- Primary DI / UDI-DI
- EPIS63420PF0 FDA UDI
- 510(k) Number
- K221048 FDA UDI
- FDA Product Code
- KRR FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Joint prosthesis implantation kit, single-use
Patellar Adjustment Socket by Episurf Operations AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221048 also covers:
- Episealer Knee Revision Guide — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Adjustment Socket — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
- Femoral Component — Episurf Operations AB
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
- Episurf Operations AB
Sources (1)
- FDA UDI eeb21911-5f9e-47ea-8be8-8d95143abc1c 34 fields · synced Jun 8, 2026