SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Poly (l-lactide-co-glycolide) Resorbable Fixation System.

Pre-market Notification Details

• Device ID: K030069
• 510k Number: K030069
• Device Name: SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
• Classification: Plate, Bone
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301
• Contact: Bonnie J Smith
• Correspondent: Bonnie J Smith; SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-08
• Decision Date: 2003-04-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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