SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX

Bone Grafting Material, Synthetic

COLLAGEN MATRIX, INC.

The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Synoss Collagen Synthetic Mineral-collagen Bone Graft Matrix.

Pre-market Notification Details

• Device ID: K083742
• 510k Number: K083742
• Device Name: SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
• Classification: Bone Grafting Material, Synthetic
• Applicant: COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes, NJ 07417
• Contact: Peggy Hansen
• Correspondent: Peggy Hansen; COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes, NJ 07417
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-16
• Decision Date: 2009-02-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841336139008	K083742	000
00841336138995	K083742	000
00841336138988	K083742	000
00841336115569	K083742	000