The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Identiti Porous Ti Interbody System, Transcend Peek Interbody System, Identiti Nanotec Interbody System, Transcend Nanotec Interbody System.
| Device ID | K211805 | 
| 510k Number | K211805 | 
| Device Name: | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | 
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar | 
| Applicant | Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 | 
| Contact | Sandy Gill | 
| Correspondent | Sandy Gill Alphatec Spine, Inc. 1950 Camino Vida Roble 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 | 2021-06-11 | 
| Decision Date | 2021-09-22 |