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Patellar Component

FDA UDI

Class II (US FDA UDI)

by Episurf Operations AB

Identity

Trade Name
Patellar Component FDA UDI
Generic Name
Partial-resurfacing patella prosthesis FDA UDI
Model / Reference
D25 FDA UDI

Identifiers

Catalog Number
61125PF FDA UDI
Primary DI / UDI-DI
EPIS61125PF0 FDA UDI
510(k) Number
K221048 FDA UDI
FDA Product Code
KRR FDA UDI
GMDN Term
Partial-resurfacing patella prosthesis 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

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: Partial-resurfacing patella prosthesis

Patellar Component by Episurf Operations AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partial-resurfacing patella prosthesis.

Cleared under the same submission

K221048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Episurf Operations AB

Sources (1)

  • FDA UDI a291e6e6-ef44-442f-94aa-2761997e4725 34 fields · synced May 31, 2026