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FDA 510(k)

GMK Total Knee System - TiNbN Coating

K-Number: K202684 · 2020-12-11

ApplicantMedacta International S.A.
Decision Date2020-12-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Total Knee System - TiNbN Coating is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K202684. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK Total Knee System - TiNbN Coating?

GMK Total Knee System - TiNbN Coating is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Medacta International S.A.. The 510(k) number is K202684.

When did GMK Total Knee System - TiNbN Coating receive FDA 510(k) clearance?

GMK Total Knee System - TiNbN Coating received FDA 510(k) clearance on 2020-12-11, under 510(k) number K202684.

Who is the listed applicant for GMK Total Knee System - TiNbN Coating?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMK Total Knee System - TiNbN Coating?

The FDA product code for GMK Total Knee System - TiNbN Coating is JWH.

Other records listing Medacta International S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254202MectaLIF 3D Metal AnteriorK253940M.U.S.T. Pedicle Screw System - ExtensionK253328GMK 3D Metal Tibial Tray ExtensionK250644MSS - Monobloc stemK251043Mpact 3D Metal Implants Extension – DMLS TechnologyK252847NextAR Hip Platform

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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