The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Bimodal Bone Graft Substitute Foam Strip.
| Device ID | K153608 |
| 510k Number | K153608 |
| Device Name: | Vitoss BiModal Bone Graft Substitute Foam Strip |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PARKWAY Malvern, PA 19355 |
| Contact | Lynn Lundy |
| Correspondent | Meriam Gabera ORTHOVITA, INC. 59 Route 17 South Allendale, NJ 07401 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-17 |
| Decision Date | 2016-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327277258 | K153608 | 000 |
| 07613327277241 | K153608 | 000 |
| 07613327277234 | K153608 | 000 |
| 07613327277227 | K153608 | 000 |