LEGION Inserts With JRNY Lock

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Inserts With Jrny Lock.

Pre-market Notification Details

• Device ID: K200407
• 510k Number: K200407
• Device Name: LEGION Inserts With JRNY Lock
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Konrad Wolfmeyer
• Correspondent: Konrad Wolfmeyer; Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-19
• Decision Date: 2020-03-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556733103	K200407	000
00885556733264	K200407	000
00885556733271	K200407	000
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