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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739161554120 | K122332 | 000 |
| M739161554035 | K122332 | 000 |
| M739161554045 | K122332 | 000 |
| M739161554050 | K122332 | 000 |
| M739161554055 | K122332 | 000 |
| M739161554060 | K122332 | 000 |
| M739161554065 | K122332 | 000 |
| M739161554070 | K122332 | 000 |
| M739161554075 | K122332 | 000 |
| M739161554080 | K122332 | 000 |
| M739161554085 | K122332 | 000 |
| M739161554090 | K122332 | 000 |
| M739161554110 | K122332 | 000 |
| M739161554030 | K122332 | 000 |