The following data is part of a premarket notification filed by Osteotech Inc with the FDA for Grafton R Ii Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices.
| Device ID | K082615 |
| 510k Number | K082615 |
| Device Name: | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | OSTEOTECH INC 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Chris Talbot |
| Correspondent | Chris Talbot OSTEOTECH INC 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2008-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169141858 | K082615 | 000 |
| 00613994986474 | K082615 | 000 |
| 00613994986481 | K082615 | 000 |
| 00613994986498 | K082615 | 000 |
| 00613994986504 | K082615 | 000 |
| 00613994986511 | K082615 | 000 |
| 00613994986528 | K082615 | 000 |
| 00613994986535 | K082615 | 000 |
| 00613994986542 | K082615 | 000 |
| 00613994986559 | K082615 | 000 |
| 00643169103986 | K082615 | 000 |
| 00643169103993 | K082615 | 000 |
| 00643169104006 | K082615 | 000 |
| 00643169104013 | K082615 | 000 |
| 00613994986467 | K082615 | 000 |