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GMK Hinge and Revision TiNbN coated

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name
GMK Hinge and Revision TiNbN coated FDA UDI
Generic Name
Coated knee tibia prosthesis FDA UDI
Device Name
TiNbN coated Revision Tibial Tray size 4 Left FDA UDI
Model / Reference
02.07.4684L FDA UDI
Description
TiNbN coated Revision Tibial Tray size 4 Left FDA UDI

Identifiers

Primary DI / UDI-DI
07630971258235 FDA UDI
510(k) Number
K210010 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Coated knee tibia 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coated knee tibia prosthesis

GMK Hinge and Revision TiNbN coated by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated knee tibia prosthesis.

Cleared under the same submission

K210010 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 ad245729-310e-4b8a-9ac2-21cc6c0e7500 34 fields · synced May 31, 2026