The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Scaffold Foam Bone Graft Material.
| Device ID | K032288 |
| 510k Number | K032288 |
| Device Name: | VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Gina M Nagvajara |
| Correspondent | Gina M Nagvajara ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2003-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232000443 | K032288 | 000 |
| 00808232000269 | K032288 | 000 |
| 00808232000276 | K032288 | 000 |
| 00808232000290 | K032288 | 000 |
| 00808232000306 | K032288 | 000 |
| 00808232000313 | K032288 | 000 |
| 00808232000375 | K032288 | 000 |
| 00808232000382 | K032288 | 000 |
| 00808232000412 | K032288 | 000 |
| 00808232000429 | K032288 | 000 |
| 00808232000436 | K032288 | 000 |
| 00808232000245 | K032288 | 000 |