510(k) K072685 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
NGARDE SYSTEM
| Applicant | N Spine, Inc., San Diego CA, US |
| Decision | Unknown, Oct 19, 2007 |
| Received | Sep 21, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072685
| 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 N-Hance System 150 mm, Catalog number NH60150-1.
spinal fusion surgery Terminated |
NQP | None listed |
| Feb 3, 2009 | Synthes Spine TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S
spinal fusion surgery Terminated |
NQP | None listed |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 200 mm, Catalog number NF60020-1.
spinal fusion surgery Terminated |
NPQ | None listed |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 150 mm, Catalog number NF60150-1.
spinal fusion surgery Terminated |
NPQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.