510(k) K992739 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
CLICK'X
| Applicant | Synthes Spine, Paoli PA, US |
| Decision | Substantially Equivalent, Feb 8, 2000 |
| Received | Aug 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992739
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2013 | Synthes USA HQ, Inc. Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072.
Intended to provide precise and segmental stabilization of the spine in skeletally mature pati Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.