510(k) K072282 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
CAPLESS LI PEDICLE SCREW SYSTEM
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, Sep 14, 2007 |
| Received | Aug 16, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072282
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2009 | X Spine Systems Inc Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile.
The Capless LI Pedicle Screw System is indicated for the treatment of sever s Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.