The following data is part of a premarket notification filed by Alphatec Spine Inc. with the FDA for Identiti Alif Standalone Interbody System.
| Device ID | K203742 |
| 510k Number | K203742 |
| Device Name: | IdentiTi ALIF Standalone Interbody System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Alphatec Spine Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Cynthia Dorne |
| Correspondent | Cynthia Dorne Alphatec Spine Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-22 |
| Decision Date | 2021-04-09 |