The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Bioactive (ba) Injectable.
| Device ID | K163621 |
| 510k Number | K163621 |
| Device Name: | Vitoss Bioactive (BA) Injectable |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 |
| Contact | John Rossman |
| Correspondent | John Rossman Stryker Corporation 59 Route 17 South Allendale, NJ 07401 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327064797 | K163621 | 000 |
| 07613327064780 | K163621 | 000 |
| 07613327064773 | K163621 | 000 |