510(k) Report

FDA applicant

N Spine, Inc.

San Diego, CA3 decisions2006–200711 recalls

FDA records 3 decisions for N Spine, Inc. (San Diego, CA) from 2006 to 2007: 3 510(k) clearances. Most are in product codes NQP (Posterior Metal/Polymer Spinal System, Fusion) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Its devices cite 12 predicates, 2 of them its own earlier devices. 11 recalls are linked to its devices.

FDA’s records also spell it “N-Spine, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided N Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

5in 2009

2008: 62009: 5
2007high 6 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — N Spine, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like N Spine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NQPPosterior Metal/Polymer Spinal System, Fusion2decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K053623Nfix Fusion SystemN-Spine, Inc. · 20062cite it
  • K061774Nfix II Pedicle Screw SystemN Spine, Inc. · 20062cite it

What has FDA decided for it lately?

  • K072685Ngarde SystemN Spine, Inc. · 20079 recalls
  • K061774Nfix II Pedicle Screw SystemN Spine, Inc. · 20067 recalls
  • K053623Nfix Fusion SystemN-Spine, Inc. · 2006

All 2 as N Spine, Inc. →The one decision as N-Spine, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K061774NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide…Feb 9, 2009
  • K061774NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended…Feb 9, 2009
  • K061774NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to…Feb 9, 2009
  • K061774N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide…Feb 9, 2009
  • K061774TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to…Feb 9, 2009
  • K061774NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgeryNov 7, 2008