510(k) K120292 ยท MNI Orthosis, Spinal Pedicle Fixation
CAPLOX II PEDICLE SCREW SYSTEM
| Applicant | Captiva Spine, Inc., Apple Valley MN, US |
| Decision | Substantially Equivalent, Apr 13, 2012 |
| Received | Jan 31, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2012 | Captiva Spine, Inc CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system.
The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stab Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.