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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 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 2016-12-21 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K163311.

When did GMK Revision Femoral Distal Augmentation receive FDA 510(k) clearance?

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

Who is the listed applicant for GMK Revision Femoral Distal Augmentation?

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 Revision Femoral Distal Augmentation?

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

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Related Devices (Code: KRO)

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.

K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UC

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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