The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Synthetic Mineral-collagen Bone Graft Matrix.
| Device ID | K092608 |
| 510k Number | K092608 |
| Device Name: | SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX |
| Classification | Filler, Bone Void, Calcium Compound |
| 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 | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-25 |
| Decision Date | 2010-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420157096 | K092608 | 000 |
| 00840420156983 | K092608 | 000 |
| 00840420156990 | K092608 | 000 |
| 00840420157003 | K092608 | 000 |
| 00840420157010 | K092608 | 000 |
| 00840420157027 | K092608 | 000 |
| 00840420157034 | K092608 | 000 |
| 00840420157041 | K092608 | 000 |
| 00840420157058 | K092608 | 000 |
| 00840420156976 | K092608 | 000 |