The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Ossimend (tm) Bone Graft Material.
| Device ID | K052812 |
| 510k Number | K052812 |
| Device Name: | OSSIMEND (TM) BONE GRAFT MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy C Hansen |
| Correspondent | Peggy C 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 | 2005-10-04 |
| Decision Date | 2006-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166128088 | K052812 | 000 |
| 00842166127968 | K052812 | 000 |
| 00842166127975 | K052812 | 000 |
| 00842166127982 | K052812 | 000 |
| 00842166127999 | K052812 | 000 |
| 00842166128002 | K052812 | 000 |
| 00842166128019 | K052812 | 000 |
| 00842166128026 | K052812 | 000 |
| 00842166128033 | K052812 | 000 |
| 00842166128040 | K052812 | 000 |
| 00842166128057 | K052812 | 000 |
| 00842166128064 | K052812 | 000 |
| 00842166128071 | K052812 | 000 |
| 00842166127951 | K052812 | 000 |