SYNTHES 6.5MM MIDFOOT FUSION BOLT

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 6.5mm Midfoot Fusion Bolt.

Pre-market Notification Details

• Device ID: K081071
• 510k Number: K081071
• Device Name: SYNTHES 6.5MM MIDFOOT FUSION BOLT
• Classification: Screw, Fixation, Bone
• Applicant: SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380
• Contact: Karl J Nittinger
• Correspondent: Karl J Nittinger; SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-15
• Decision Date: 2008-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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