510(k) K132365 ยท MNI Orthosis, Spinal Pedicle Fixation
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
| Applicant | Accel Spine, Dallas TX, US |
| Decision | Substantially Equivalent, Aug 20, 2013 |
| Received | Jul 30, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2019 | CTL Medical Corporation CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 Terminated |
MNI | None listed |
| Mar 20, 2019 | CTL Medical Corporation CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.