510(k) Report

FDA applicant

Sanacor

American Fork, UT3 decisions2007–20090 recalls

FDA records 3 decisions for Sanacor (American Fork, UT) from 2007 to 2009: 3 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 13 predicates, 0 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 Sanacor’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sanacor 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
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K070933Lowtop Pedicle Screw SystemSanacor · 20072cite it
  • K090477Alpine Pedicle Screw SystemSanacor · 20091cites it

What has FDA decided for it lately?

  • K090477Alpine Pedicle Screw SystemSanacor · 2009
  • K073500Active Anterior Cervical Plate SystemSanacor · 2008
  • K070933Lowtop Pedicle Screw SystemSanacor · 2007

All 3 as Sanacor →