Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GMK Revision & Hinge Extension - TiNbN Coating

K-Number: K210010 · 2021-03-02

ApplicantMedacta International S.A.
Decision Date2021-03-02
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Revision & Hinge Extension - TiNbN Coating is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-03-02 under approval number K210010. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK Revision & Hinge Extension - TiNbN Coating?

GMK Revision & Hinge Extension - TiNbN Coating is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Medacta International S.A.. The 510(k) number is K210010.

When was GMK Revision & Hinge Extension - TiNbN Coating approved by the FDA?

GMK Revision & Hinge Extension - TiNbN Coating received FDA 510(k) clearance on 2021-03-02, under approval number K210010.

What company makes GMK Revision & Hinge Extension - TiNbN Coating?

GMK Revision & Hinge Extension - TiNbN Coating is manufactured by Medacta International S.A..

What is the FDA product code for GMK Revision & Hinge Extension - TiNbN Coating?

The FDA product code for GMK Revision & Hinge Extension - TiNbN Coating is KRO.

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 devices →

Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

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.

↑