The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Grafton Dbm.
| Device ID | K051188 |
| 510k Number | K051188 |
| Device Name: | GRAFTON DBM |
| Classification | Bone Grafting Material, Human Source |
| Applicant | OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Contact | Christopher Talbot |
| Correspondent | Christopher Talbot OSTEOTECH, INC. 51 JAMES WAY Eatontown, NJ 07724 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-10 |
| Decision Date | 2006-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169134577 | K051188 | 000 |
| 00643169134287 | K051188 | 000 |
| 00643169123090 | K051188 | 000 |
| 00613994985910 | K051188 | 000 |
| 00613994985798 | K051188 | 000 |
| 00643169965010 | K051188 | 000 |
| 00643169965003 | K051188 | 000 |
| 00643169964976 | K051188 | 000 |
| 00643169964969 | K051188 | 000 |
| 00643169134294 | K051188 | 000 |
| 00643169134300 | K051188 | 000 |
| 00643169134560 | K051188 | 000 |
| 00643169134553 | K051188 | 000 |
| 00643169134546 | K051188 | 000 |
| 00643169134539 | K051188 | 000 |
| 00643169134508 | K051188 | 000 |
| 00643169134492 | K051188 | 000 |
| 00643169134485 | K051188 | 000 |
| 00643169134478 | K051188 | 000 |
| 00643169964952 | K051188 | 000 |