SYNTHES (USA) LATERAL ENTRY 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) Lateral Entry Femoral Nail System.

Pre-market Notification Details

• Device ID: K040336
• 510k Number: K040336
• Device Name: SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301
• Contact: Sheri Musgnung
• Correspondent: Sheri Musgnung; 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: 2004-02-11
• Decision Date: 2004-04-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H67904003268S0	K040336	000
H67904003353S0	K040336	000
H67904003356S0	K040336	000
H67904003357S0	K040336	000
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H679040030340	K040336	000
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H679040030360	K040336	000
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H67904003560S0	K040336	000
H67904003561S0	K040336	000
H67904003564S0	K040336	000
H67904003565S0	K040336	000
H67904003568S0	K040336	000
H67904003653S0	K040336	000
H67904003656S0	K040336	000
H67904003741S0	K040336	000
H67904003744S0	K040336	000
H67904003745S0	K040336	000
H67904003748S0	K040336	000
H67904003749S0	K040336	000
H67904003752S0	K040336	000
H67904003753S0	K040336	000
H67904003756S0	K040336	000
H67904003757S0	K040336	000
H67904003760S0	K040336	000
H67904003740S0	K040336	000
H67904003677S0	K040336	000
H67904003657S0	K040336	000
H67904003660S0	K040336	000
H67904003661S0	K040336	000
H67904003664S0	K040336	000
H67904003665S0	K040336	000
H67904003668S0	K040336	000
H67904003669S0	K040336	000
H67904003672S0	K040336	000
H67904003673S0	K040336	000
H67904003676S0	K040336	000
H67904003761S0	K040336	000