LEGION Knee System
K-Number: K180334 · 2018-03-05
ApplicantSmith & Nephew, Inc.
Decision Date2018-03-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
LEGION Knee System is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2018-03-05 under approval number K180334. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LEGION Knee System?
LEGION Knee System is a medical device that received FDA 510(k) clearance on 2018-03-05. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K180334.
When was LEGION Knee System approved by the FDA?
LEGION Knee System received FDA 510(k) clearance on 2018-03-05, under approval number K180334.
What company makes LEGION Knee System?
LEGION Knee System is manufactured by Smith & Nephew, Inc..
What is the FDA product code for LEGION Knee System?
The FDA product code for LEGION Knee System is JWH.
Related Clinical Trials
Other Devices by Smith & Nephew, Inc.
Related Devices (Code: JWH)
K160515PS2 Knee SystemConsensus Orthopedics, Inc.
K160771Destiknee Total Knee SystemMeril Healthcare Private Limited
K160157LOSPA Modular Knee SystemCorentec Co., Ltd.
K162273Materialise TKA Guide SystemMaterialise NV
K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.
K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.
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.