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GMK 3D Metal Tibial Tray

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name
GMK 3D Metal Tibial Tray FDA UDI
Generic Name
Trabeculated bicondylar knee tibia prosthesis FDA UDI
Device Name
3DMetal Tibial Tray Size 4R FDA UDI
Model / Reference
02.12.3D04R FDA UDI
Description
3DMetal Tibial Tray Size 4R FDA UDI

Identifiers

Primary DI / UDI-DI
07630345710840 FDA UDI
510(k) Number
K221850 FDA UDI
FDA Product Code
JWH FDA UDI
MBH FDA UDI
GMDN Term
Trabeculated bicondylar knee tibia prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
888.3565 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: Trabeculated bicondylar knee tibia prosthesis

GMK 3D Metal Tibial Tray by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trabeculated bicondylar knee tibia prosthesis.

Cleared under the same submission

K221850 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 cadf8e9c-f9c6-40d6-ab12-ecc90344d3b1 34 fields · synced Jun 1, 2026