SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Retrograde/antegrade Femoral Nail System.

Pre-market Notification Details

• Device ID: K033618
• 510k Number: K033618
• Device Name: SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301
• Contact: Bonnie Smith
• Correspondent: Bonnie Smith; SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-11-18
• Decision Date: 2004-02-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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