510(k) K113011 ยท MRW System, Facet Screw Spinal Device
SPARTAN S3 FACET SYSTEM
| Applicant | Amendia, Inc., Apple Valley MN, US |
| Decision | Substantially Equivalent, Dec 6, 2011 |
| Received | Oct 11, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113011
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.