The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Ba Bimodal Bioactive Bone Graft Substitute.
| Device ID | K103173 |
| 510k Number | K103173 |
| Device Name: | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-28 |
| Decision Date | 2011-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232001341 | K103173 | 000 |
| 00808232001334 | K103173 | 000 |
| 00808232001327 | K103173 | 000 |
| 00808232001310 | K103173 | 000 |
| 00808232000658 | K103173 | 000 |
| 00808232000641 | K103173 | 000 |
| 00808232000634 | K103173 | 000 |
| 00808232000627 | K103173 | 000 |