LEGION Inserts with JRNY Lock
K-Number: K200407 · 2020-03-13
ApplicantSmith & Nephew, Inc.
Decision Date2020-03-13
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
LEGION Inserts with JRNY Lock is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2020-03-13 under approval number K200407. 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 Inserts with JRNY Lock?
LEGION Inserts with JRNY Lock is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K200407.
When was LEGION Inserts with JRNY Lock approved by the FDA?
LEGION Inserts with JRNY Lock received FDA 510(k) clearance on 2020-03-13, under approval number K200407.
What company makes LEGION Inserts with JRNY Lock?
LEGION Inserts with JRNY Lock is manufactured by Smith & Nephew, Inc..
What is the FDA product code for LEGION Inserts with JRNY Lock?
The FDA product code for LEGION Inserts with JRNY Lock is JWH.
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.