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 |