The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Cortoss Bone Augmentation Material.
| Device ID | K080108 |
| 510k Number | K080108 |
| Device Name: | CORTOSS BONE AUGMENTATION MATERIAL |
| Classification | Cement, Bone, Vertebroplasty |
| 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 | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-15 |
| Decision Date | 2009-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30808232000949 | K080108 | 000 |
| 00808232001372 | K080108 | 000 |
| 00808232000979 | K080108 | 000 |
| 00808232000962 | K080108 | 000 |
| 00808232000917 | K080108 | 000 |