510(k) K061342 ยท NKB Thoracolumbosacral Pedicle Screw System
MALIBU SPINAL SYSTEM
| Applicant | Seaspine, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Oct 25, 2006 |
| Received | Apr 15, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2014 | Integra LifeSciences Corp. Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109;
Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110.
510(k):
91-2109 K061342.
91-2110 K051942.
The Malibu" System is int Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.