The following data is part of a premarket notification filed by Captiva Spine, Inc with the FDA for Captiva Spine Caplox Ii Spinal Fixation System.
| Device ID | K111115 |
| 510k Number | K111115 |
| Device Name: | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | CAPTIVA SPINE, INC 2361 NW 105TH LANE Sunrise, FL 33322 |
| Contact | John Sanders |
| Correspondent | John Sanders CAPTIVA SPINE, INC 2361 NW 105TH LANE Sunrise, FL 33322 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-09-13 |
| Summary: | summary |