FDA 510(k)

SEMI-CONSTRAINT KEE JOINT HINGE PROSTH

K-Number: K811105 · 1981-07-27

Decision Date1981-07-27

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SEMI-CONSTRAINT KEE JOINT HINGE PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Allo Pro Corp.. It received FDA 510(k) clearance on 1981-07-27 under 510(k) number K811105. 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 SEMI-CONSTRAINT KEE JOINT HINGE PROSTH?

SEMI-CONSTRAINT KEE JOINT HINGE PROSTH is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Allo Pro Corp.. The 510(k) number is K811105.

When did SEMI-CONSTRAINT KEE JOINT HINGE PROSTH receive FDA 510(k) clearance?

SEMI-CONSTRAINT KEE JOINT HINGE PROSTH received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811105.

Who is the listed applicant for SEMI-CONSTRAINT KEE JOINT HINGE PROSTH?

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

What is the FDA product code for SEMI-CONSTRAINT KEE JOINT HINGE PROSTH?

The FDA product code for SEMI-CONSTRAINT KEE JOINT HINGE 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.