The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Identiti Porous Ti Interbody System.
Device ID | K183705 |
510k Number | K183705 |
Device Name: | IdentiTi Porous Ti Interbody System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
Product Code | MAX |
Subsequent Product Code | ODP |
Subsequent Product Code | OVD |
Subsequent Product Code | PHM |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-31 |
Decision Date | 2019-03-01 |
Summary: | summary |