The following data is part of a premarket notification filed by Captiva Spine, Inc with the FDA for Caplox Ii Pedicle Screw System.
| Device ID | K120292 |
| 510k Number | K120292 |
| Device Name: | CAPLOX II PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | CAPTIVA SPINE, INC 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen CAPTIVA SPINE, INC 13540 GUILD AVE Apple Valley, 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 | 2012-01-31 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739245521900 | K120292 | 000 |
| M739245521700 | K120292 | 000 |
| M739245521500 | K120292 | 000 |
| M739245521300 | K120292 | 000 |
| M739245501900 | K120292 | 000 |
| M739245501800 | K120292 | 000 |
| M739245501700 | K120292 | 000 |
| M739245501500 | K120292 | 000 |
| M739245501300 | K120292 | 000 |