510(k) Report

FDA applicant

Us Spine

Apple Valley, MN5 decisions2006–20080 recalls

FDA records 5 decisions for Us Spine (Apple Valley, MN) from 2006 to 2008: 5 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and ODP (Intervertebral Fusion Device With Bone Graft…). Its devices cite 20 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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 Us Spine’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2008: 3
2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MRWSystem, Facet Screw Spinal Device1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Whose devices does it build on?

Its devices cite 20 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 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.

  • K082801Phantom Plus Cage SystemUs Spine · 200813cite it
  • K061041US Spine Facet Fixation SystemUs Spine · 20062cite it
  • K062785LTD Polyaxial Fixation SystemUs Spine · 20062cite it
  • K081296Preference Pedicle Screw SystemUs Spine · 20081cites it
  • K081883Modification to Preference Pedicle Screw SystemUs Spine · 20081cites it

What has FDA decided for it lately?

  • K082801Phantom Plus Cage SystemUs Spine · 2008
  • K081883Modification to Preference Pedicle Screw SystemUs Spine · 2008
  • K081296Preference Pedicle Screw SystemUs Spine · 2008
  • K062785LTD Polyaxial Fixation SystemUs Spine · 2006
  • K061041US Spine Facet Fixation SystemUs Spine · 2006

All 5 as Us Spine →