The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Invictus Spinal Fixation System.
| Device ID | K213460 |
| 510k Number | K213460 |
| 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 | 2021-10-27 |
| Decision Date | 2021-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376450322 | K213460 | 000 |