510(k) K052144 ยท NKB Thoracolumbosacral Pedicle Screw System
TSRH SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 31, 2005 |
| Received | Aug 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2007 | Medtronic Sofamor Danek USA Inc Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131 Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.