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FDA 510(k)

GMK Revision Femoral Distal Augmentation

K-Number: K163311 · 2016-12-21

ApplicantMedacta International S.A.
Decision Date2016-12-21
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Revision Femoral Distal Augmentation is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2016-12-21 under approval number K163311. 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 Femoral Distal Augmentation?

GMK Revision Femoral Distal Augmentation is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Medacta International S.A.. The 510(k) number is K163311.

When was GMK Revision Femoral Distal Augmentation approved by the FDA?

GMK Revision Femoral Distal Augmentation received FDA 510(k) clearance on 2016-12-21, under approval number K163311.

What company makes GMK Revision Femoral Distal Augmentation?

GMK Revision Femoral Distal Augmentation is manufactured by Medacta International S.A..

What is the FDA product code for GMK Revision Femoral Distal Augmentation?

The FDA product code for GMK Revision Femoral Distal Augmentation is KRO.

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Other Devices by Medacta International S.A.

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 K172347GMK Hinge, GMK Revision

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Related Devices (Code: KRO)

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) K190100USTAR II SystemUnited Orthopedic Corporation

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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