510(k) K062391 ยท MRW System, Facet Screw Spinal Device
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
| Applicant | Triage Medical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 14, 2006 |
| Received | Aug 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2011 | Interventional Spine Inc PERPOS PLS, CATALOG #'s 9045-01 & 9045-02
A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an a Terminated |
MRW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.