SYNTHES (USA) TIBIAL NAIL SYSTEM EX

Nail, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Tibial Nail System Ex.

Pre-market Notification Details

• Device ID: K040762
• 510k Number: K040762
• Device Name: SYNTHES (USA) TIBIAL NAIL SYSTEM EX
• Classification: Nail, Fixation, Bone
• Applicant: SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222
• Contact: Sheri L Musgnung
• Correspondent: Sheri L Musgnung; SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222
• Product Code: JDS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-03-25
• Decision Date: 2004-04-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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