The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Bioactive Foam Bone Graft Substitute.
| Device ID | K072184 |
| 510k Number | K072184 |
| Device Name: | VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE |
| 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 | 2007-08-06 |
| Decision Date | 2007-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232000481 | K072184 | 000 |
| 00808232000474 | K072184 | 000 |
| 00808232000467 | K072184 | 000 |
| 00808232000450 | K072184 | 000 |