510(k) K083089 ยท NKB Thoracolumbosacral Pedicle Screw System
NEWPORT SPINAL SYSTEM
| Applicant | Seaspine, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Jan 13, 2009 |
| Received | Oct 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083089
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2014 | Integra LifeSciences Corp. Integra NewPort MIS System
Model No.
NWPIMP (NewPort Implant Tray w/ Components)
NWP2INSTP (NewPort Instrument Tray w/ Components)
The NewPort System is intended to be used as a temporary or Terminated |
NKB | None listed |
| Jul 1, 2014 | Integra LifeSciences Corp. MIS Rod 2, a component of the NewPort System.
Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm).
The NewPort MIS Rod 2 is a 5.5 diameter titani Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.