The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Bonesave Bone Void Filler.
| Device ID | K033258 |
| 510k Number | K033258 |
| Device Name: | BONESAVE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Lorraine Montemurro |
| Correspondent | Lorraine Montemurro HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-09 |
| Decision Date | 2004-03-09 |
| Summary: | summary |