510(k) K984522 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION OF TSRH SPINAL SYSTEM
| Applicant | Danek Medical, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Jan 6, 1999 |
| Received | Dec 21, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K984522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2011 | Medtronic Sofamor Danek USA Inc TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA.
Product Usage: TSRH(R) Spinal System is intended to help prov Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.