510(k) K080407 ยท MNI Orthosis, Spinal Pedicle Fixation
BLACKSTONE SFS PARALLEL ROD CONNECTORS
| Applicant | Blackstone Medical, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Mar 13, 2008 |
| Received | Feb 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080407
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2013 | Orthofix, Inc Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700).
Product Usage:
The connector assemblies allow for rod components to be connected side-to-side, o Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.