The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Lateral Interbody System.
| Device ID | K191311 |
| 510k Number | K191311 |
| Device Name: | ATEC Lateral 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 | 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 | 2019-05-15 |
| Decision Date | 2019-08-12 |