The following data is part of a premarket notification filed by Orthovita, Inc. with the FDA for Orthovita Peek Spacer.
| Device ID | K101171 |
| 510k Number | K101171 |
| Device Name: | ORTHOVITA PEEK SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Catherine V Moffa |
| Correspondent | Catherine V Moffa ORTHOVITA, INC. 45 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2011-01-25 |
| Summary: | summary |