510(k) K120832 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
FORTEX PEDICLE SCREW SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Oct 23, 2012 |
| Received | Mar 19, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2017 | XTANT MEDICAL INC 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag.
Product Usage:
The 5.5mm dia. X 500 mm CoCr Straight Rod is an acces Terminated |
MNH | None listed |
| Jun 22, 2015 | X Spine Systems Inc Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 Terminated |
MNH | None listed |
| Apr 22, 2015 | X Spine Systems Inc Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.