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 |