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GMK Revision Total Knee System

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name
GMK Revision Total Knee System FDA UDI
Generic Name
Knee arthroplasty wedge FDA UDI
Device Name
Femoral wedge distal 8mm, size 4 FDA UDI
Model / Reference
02.05.04DW FDA UDI
Description
Femoral wedge distal 8mm, size 4 FDA UDI

Identifiers

Primary DI / UDI-DI
07630030814822 FDA UDI
510(k) Number
K102437 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Knee arthroplasty wedge 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Knee arthroplasty wedge

GMK Revision Total Knee System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee arthroplasty wedge.

Cleared under the same submission

K102437 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medacta International

Sources (1)

  • FDA UDI 1cefc243-7833-4555-a79c-d32c167f561e 34 fields · synced May 30, 2026