FDA 510(k)

MAK OSS KNEE FEMORAL COMPONENTS

K-Number: K083779 · 2009-04-03

Decision Date2009-04-03

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MAK OSS KNEE FEMORAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2009-04-03 under 510(k) number K083779. 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 KNEE FEMORAL COMPONENTS?

MAK OSS KNEE FEMORAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2009-04-03. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K083779.

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

MAK OSS KNEE FEMORAL COMPONENTS received FDA 510(k) clearance on 2009-04-03, under 510(k) number K083779.

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

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

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

The FDA product code for MAK OSS KNEE FEMORAL COMPONENTS is KRO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomet Manufacturing Corp as applicant

K230540Patient Specific Planning Solution™ 3D Bone Models K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner K202232Comprehensive Vault Reconstruction System K193038Comprehensive Shoulder System K182516Comprehensive Nano Stemless Shoulder

View all 82 devices →

Related Devices (Code: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics 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 Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC K240043EVOLUTION® 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

View on FDA Database →

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