The following data is part of a premarket notification filed by Alphatec Spine, Inc with the FDA for Atec Universal Spacer System.
| Device ID | K180480 |
| 510k Number | K180480 |
| Device Name: | ATEC Universal Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Thoracic |
| Applicant | Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | PHM |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-23 |
| Decision Date | 2018-05-31 |
| Summary: | summary |