510(k) K043351 ยท MRW System, Facet Screw Spinal Device
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
| Applicant | Triage Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Dec 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043351
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2011 | Interventional Spine Inc Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant
A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of Terminated |
MRW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.