510(k) Report

FDA applicant

U&I Corp., America

Murray, UT3 decisions2003–20035 recalls

FDA records 3 decisions for U&I Corp., America (Murray, UT) in 2003: 3 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and KWP (Appliance, Fixation, Spinal Interlaminal). Its devices cite 9 predicates, 0 of them its own earlier devices. 5 recalls are 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 U&I Corp., America’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for U&I Corp., America since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — U&I Corp., America by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 74 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.

  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 200341cite it
  • K024096Optima, Spinal SystemU&I Corp., America · 200330cite it
  • K031595U & I America Spinal Hook SystemU&I Corp., America · 20033cite it

What has FDA decided for it lately?

  • K031585U&I, Optima, Spinal SystemU&I Corp., America · 20035 recalls
  • K031595U & I America Spinal Hook SystemU&I Corp., America · 20033 recalls
  • K024096Optima, Spinal SystemU&I Corp., America · 20033 recalls

All 3 as U&I Corp., America →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K020279Optima Spinal System and Spinal Hook System, set screw component.Aug 10, 2004
  • K0202794mm Hex DriverJan 14, 2004
  • K0202792.5mm Hex DriverJan 14, 2004
  • K031585Optima Large Poly Screw DriverAug 18, 2003
  • K020279Optima Poly Screw Driver.Aug 18, 2003