TRIGEN STRAIGHT HUMERAL NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

SMITH & NEPHEW, INC.

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

Pre-market Notification Details

• Device ID: K032722
• 510k Number: K032722
• Device Name: TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Janet Johnson Akil
• Correspondent: Janet Johnson Akil; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-09-03
• Decision Date: 2003-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03596010514431	K032722	000
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