SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM

Plate, Bone

SYNTHES (USA)

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

Pre-market Notification Details

• Device ID: K083388
• 510k Number: K083388
• Device Name: SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
• Classification: Plate, Bone
• Applicant: SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Contact: Andrea M Tasker
• Correspondent: Andrea M Tasker; SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-17
• Decision Date: 2009-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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