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 |