The following data is part of a premarket notification filed by Captiva Spine with the FDA for Captiva Spine And Caplox Ii/towerlox Pedicle Screw System.
Device ID | K160020 |
510k Number | K160020 |
Device Name: | Captiva Spine And CapLOX II/TowerLOX Pedicle Screw System |
Classification | Orthosis, Spondylolisthesis Spinal Fixation |
Applicant | Captiva Spine 967 N. Alternate A1A Ste 1 Jupiter, FL 33477 |
Contact | Tamala J. Wampler |
Correspondent | Kennneth C. Maxwell Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-05 |
Decision Date | 2016-03-02 |
Summary: | summary |