SMITH & NEPHEW RAIL SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Rail System.

Pre-market Notification Details

• Device ID: K090926
• 510k Number: K090926
• Device Name: SMITH & NEPHEW RAIL SYSTEM
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Laura Medlin
• Correspondent: Laura Medlin; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-02
• Decision Date: 2009-06-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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