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 |