The following data is part of a premarket notification filed by Captiva Spine with the FDA for Caplox Ii Pedicle Screw System/towerlox Pedicle Screw System.
| Device ID | K131538 |
| 510k Number | K131538 |
| Device Name: | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2013-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M73924714975 | K131538 | 000 |
| M73924713752 | K131538 | 000 |
| M73924713139 | K131538 | 000 |
| M73924712832 | K131538 | 000 |