The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Invictus™ Oct Spinal Fixation System.
| Device ID | K203125 |
| 510k Number | K203125 |
| Device Name: | Invictus™ OCT Spinal Fixation System |
| Classification | Posterior Cervical Screw System |
| Applicant | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Ruby Zheng |
| Correspondent | Ruby Zheng Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-19 |
| Decision Date | 2020-12-18 |