510(k) Report

FDA applicant

Forex Corp.

Murray, UT1 decision2002–20024 recalls

FDA records 1 decision for Forex Corp. (Murray, UT) in 2002: 1 510(k) clearance. All are in product code MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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 Forex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Forex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Forex Corp. 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?

  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K020279Forex Corporation, Optima, Spinal SystemForex Corp. · 20029cite it

What has FDA decided for it lately?

  • K020279Forex Corporation, Optima, Spinal SystemForex Corp. · 20024 recalls

The one decision as Forex Corp. →

What has been recalled?

4 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
  • K020279Optima Poly Screw Driver.Aug 18, 2003