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FDA 510(k)

MAK OSS FEMORAL KNEE COMPONENTS

K-Number: K131393 · 2013-10-24

ApplicantBiomet Orthopedics Corp.
Decision Date2013-10-24
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAK OSS FEMORAL KNEE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics Corp.. It received FDA 510(k) clearance on 2013-10-24 under 510(k) number K131393. 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 MAK OSS FEMORAL KNEE COMPONENTS?

MAK OSS FEMORAL KNEE COMPONENTS is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Biomet Orthopedics Corp.. The 510(k) number is K131393.

When did MAK OSS FEMORAL KNEE COMPONENTS receive FDA 510(k) clearance?

MAK OSS FEMORAL KNEE COMPONENTS received FDA 510(k) clearance on 2013-10-24, under 510(k) number K131393.

Who is the listed applicant for MAK OSS FEMORAL KNEE COMPONENTS?

The FDA 510(k) record lists Biomet Orthopedics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAK OSS FEMORAL KNEE COMPONENTS?

The FDA product code for MAK OSS FEMORAL KNEE COMPONENTS 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.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® 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.

Official Source

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

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