510(k) K092371 ยท GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
SWIFT-LOCK ANCHOR, MODEL 1192
| Applicant | Advanced Neuromodulation Systems, Plano TX, US |
| Decision | Substantially Equivalent, Dec 23, 2009 |
| Received | Aug 5, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092371
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 21, 2010 | Advanced Neuromodulation Systems, Inc Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company.
Product is intended to be used as an accessory to the leads component of ANS SCS systems, functio Terminated |
GZB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.