The following data is part of a premarket notification filed by Captiva Spine with the FDA for Towerlox Pedicle Screw System.
| Device ID | K122332 |
| 510k Number | K122332 |
| Device Name: | TOWERLOX PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | CAPTIVA SPINE 13540 GUILD AVE Apple Vally, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen CAPTIVA SPINE 13540 GUILD AVE Apple Vally, MN 55124 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-02 |
| Decision Date | 2012-10-16 |
| Summary: | summary |