510(k) K061774 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
NFIX II PEDICLE SCREW SYSTEM
| Applicant | N Spine, Inc., San Diego CA, US |
| Decision | Unknown, Dec 13, 2006 |
| Received | Jun 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061774
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2010 | Synthes USA (HQ), Inc. TI N-Hance Rod 150mm Sterile
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chro Terminated |
NQP | None listed |
| Sep 1, 2010 | Synthes USA (HQ), Inc. N-Hance System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic inst Terminated |
NQP | None listed |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFix II System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic inst Terminated |
NQP | None listed |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFlex Straight monosegmental L 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute Terminated |
NQP | None listed |
| Sep 1, 2010 | Synthes USA (HQ), Inc. NFlex Stabilization System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and Terminated |
NQP | None listed |
| Feb 3, 2009 | Synthes Spine NFix II System 150 mm, Catalog number NX60150-1
spinal fusion surgery Terminated |
NQP | None listed |
| Feb 3, 2009 | Synthes Spine NFix II System 200 mm, Catalog number NX60200-1.
spinal fusion surgery Terminated |
NQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.