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 |