510(k) Report

FDA applicant

Levtech, Inc.

Jacksonville, FL5 decisions1985–19910 recalls

FDA records 5 decisions for Levtech, Inc. (Jacksonville, FL) from 1985 to 1991: 5 510(k) clearances. Most are in product codes JDQ (Cerclage, Fixation) and HWC (Screw, Fixation, Bone). 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 Levtech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Levtech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Levtech, Inc. 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?

  • JDQCerclage, Fixation1decision
  • HWCScrew, Fixation, Bone1decision
  • HAXTong, Skull For Traction1decision
  • HTDForceps1decision
  • KWPAppliance, Fixation, Spinal Interlaminal1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K850039Halifax Spinal ClampLevtech, Inc. · 19852cite it

What has FDA decided for it lately?

  • K910128Levtech Titanium Bone WireLevtech, Inc. · 1991
  • K901144Levtech Bone ScrewLevtech, Inc. · 1990
  • K873693Levtech Composite Traction TongsLevtech, Inc. · 1988
  • K874023Levtech Clamp ApplierLevtech, Inc. · 1987
  • K850039Halifax Spinal ClampLevtech, Inc. · 1985

All 5 as Levtech, Inc. →