The following data is part of a premarket notification filed by Osteotech, Inc. with the FDA for Grafton Plus Dbm Paste.
| Device ID | K043048 |
| 510k Number | K043048 |
| Device Name: | GRAFTON PLUS DBM PASTE |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| 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 | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-04 |
| Decision Date | 2005-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169134393 | K043048 | 000 |
| 00643169965096 | K043048 | 000 |
| 00613994985644 | K043048 | 000 |
| 00613994985651 | K043048 | 000 |
| 00613994985668 | K043048 | 000 |
| 00613994986191 | K043048 | 000 |
| 00613994986207 | K043048 | 000 |
| 00613994986214 | K043048 | 000 |
| 00643169122949 | K043048 | 000 |
| 00643169123021 | K043048 | 000 |
| 00643169123038 | K043048 | 000 |
| 00643169134324 | K043048 | 000 |
| 00643169134379 | K043048 | 000 |
| 00643169134386 | K043048 | 000 |
| 00643169965102 | K043048 | 000 |