FDA 510(k)

KNEE SYSTEM, QUADRAXIAL CONSTRAINED

K-Number: K781971 · 1979-04-04

Decision Date1979-04-04

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

KNEE SYSTEM, QUADRAXIAL CONSTRAINED is the device name listed in this FDA 510(k) record. The listed applicant is Hexcel Medical. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K781971. 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 KNEE SYSTEM, QUADRAXIAL CONSTRAINED?

KNEE SYSTEM, QUADRAXIAL CONSTRAINED is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Hexcel Medical. The 510(k) number is K781971.

When did KNEE SYSTEM, QUADRAXIAL CONSTRAINED receive FDA 510(k) clearance?

KNEE SYSTEM, QUADRAXIAL CONSTRAINED received FDA 510(k) clearance on 1979-04-04, under 510(k) number K781971.

Who is the listed applicant for KNEE SYSTEM, QUADRAXIAL CONSTRAINED?

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

What is the FDA product code for KNEE SYSTEM, QUADRAXIAL CONSTRAINED?

The FDA product code for KNEE SYSTEM, QUADRAXIAL CONSTRAINED is KRO.

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Other records listing Hexcel Medical as applicant

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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

View on FDA Database →

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