510(k) K042210 ยท MNI Orthosis, Spinal Pedicle Fixation
MSD SILO SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Nov 4, 2004 |
| Received | Aug 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2007 | Medtronic Sofamor Danek Instrument Manufacturing Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufact Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.