510(k) K102438 ยท MRW System, Facet Screw Spinal Device
PRIMALOK FACET FIXATION SYSTEM
| Applicant | Osteomed LP, Chesterland OH, US |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | Aug 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2011 | Osteomed, Lp OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001 Terminated |
MRW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.