FDA 510(k)

LEGION HINGE KNEE SYSTEM

K-Number: K081111 · 2008-07-23

Decision Date2008-07-23

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LEGION HINGE KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2008-07-23 under 510(k) number K081111. 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 LEGION HINGE KNEE SYSTEM?

LEGION HINGE KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K081111.

When did LEGION HINGE KNEE SYSTEM receive FDA 510(k) clearance?

LEGION HINGE KNEE SYSTEM received FDA 510(k) clearance on 2008-07-23, under 510(k) number K081111.

Who is the listed applicant for LEGION HINGE KNEE SYSTEM?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGION HINGE KNEE SYSTEM?

The FDA product code for LEGION HINGE KNEE SYSTEM is KRO.

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Other records listing Smith & Nephew, Inc. 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.