The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Kodiak Spinal Fixation System.
Device ID | K181677 |
510k Number | K181677 |
Device Name: | Kodiak Spinal Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
Contact | Cynthia Adams |
Correspondent | Cynthia Adams Alphatec Spine, Inc. 5818 El Camino Real 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 | 2018-06-26 |
Decision Date | 2018-08-09 |
Summary: | summary |