510(k) K122145 ยท NKB Thoracolumbosacral Pedicle Screw System
LANX SPINAL FIXATION SYSTEM
| Applicant | Lanx, Inc., Broomfield CO, US |
| Decision | Substantially Equivalent, Aug 17, 2012 |
| Received | Jul 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2015 | Biomet Spine, LLC Set Screw 5.5 mm Rod - Model #7703-1600.
Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tul Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.