SYNTHES ADOLESCENT 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 Adolescent Lateral Entry Femoral Nail System.

Pre-market Notification Details

• Device ID: K070843
• 510k Number: K070843
• Device Name: SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Contact: Sheri L Musgnung
• Correspondent: Sheri L Musgnung; SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-27
• Decision Date: 2007-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H67904031935S0	K070843	000
H679040310350	K070843	000
H67904031034S0	K070843	000
H679040310340	K070843	000
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H679040310200	K070843	000
H679030105090	K070843	000
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H679030104830	K070843	000
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H67904031023S0	K070843	000
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H679040310280	K070843	000
H67904031027S0	K070843	000
H679040310270	K070843	000
H67904031026S0	K070843	000
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H67904031025S0	K070843	000
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H67904031941S0	K070843	000
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H67904031950S0	K070843	000
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H67904031956S0	K070843	000
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H67904031954S0	K070843	000
H67904031953S0	K070843	000
H67904031952S0	K070843	000
H67904031936S0	K070843	000