LEGION STEM WITH HOLES

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 Stem With Holes.

Pre-market Notification Details

• Device ID: K072531
• 510k Number: K072531
• Device Name: LEGION STEM WITH HOLES
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Megan Bevill
• Correspondent: Megan Bevill; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-09-07
• Decision Date: 2007-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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