FDA 510(k)

VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.

K-Number: K821340 · 1982-05-27

Decision Date1982-05-27

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821340. 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 VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.?

VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is Intermedics Orthopedics. The 510(k) number is K821340.

When did VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. receive FDA 510(k) clearance?

VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821340.

Who is the listed applicant for VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.?

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

What is the FDA product code for VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.?

The FDA product code for VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. is KRO.

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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

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