Smith And Nephew Legion Hinge Knee System

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

SMITH & NEPHEW

The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Smith And Nephew Legion Hinge Knee System.

Pre-market Notification Details

• Device ID: K151118
• 510k Number: K151118
• Device Name: Smith And Nephew Legion Hinge Knee System
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: SMITH & NEPHEW 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Contact: Allison Chan
• Correspondent: Allison Chan; SMITH & NEPHEW 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-27
• Decision Date: 2015-07-28
• Summary: summary

NIH GUDID Devices

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