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 |