The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Invictus® Spinal Fixation System.
| Device ID | K214006 |
| 510k Number | K214006 |
| Device Name: | Invictus® Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-22 |
| Decision Date | 2022-04-04 |