The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Psx Interbody System.
| Device ID | K211873 |
| 510k Number | K211873 |
| Device Name: | PSX Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 |
| Contact | Cynthia Dorne |
| Correspondent | Cynthia Dorne Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-17 |
| Decision Date | 2021-08-10 |
| Summary: | summary |