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.
| 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 |