The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Vitoss Bioactive Foam Pack Bone Graft Substitute.
| Device ID | K081439 |
| 510k Number | K081439 |
| Device Name: | VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | David J Mcilhenny |
| Correspondent | David J Mcilhenny 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 | 2008-05-22 |
| Decision Date | 2008-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00808232000528 | K081439 | 000 |
| 00808232000511 | K081439 | 000 |
| 00808232000504 | K081439 | 000 |
| 00808232000498 | K081439 | 000 |