510(k) Report

FDA applicant

Aap International, Ltd.

Bedminster, NJ2 decisions1992–19920 recalls

FDA records 2 decisions for Aap International, Ltd. (Bedminster, NJ) in 1992: 2 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) 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 Aap International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aap International, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aap International, Ltd. 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?

  • HRSPlate, Fixation, Bone1decision
  • HWCScrew, Fixation, Bone1decision

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.

  • K915315Aap Bone PlateAap International, Ltd. · 19921cites it
  • K915316Aap Bone ScrewAap International, Ltd. · 19921cites it

What has FDA decided for it lately?

  • K915315Aap Bone PlateAap International, Ltd. · 1992
  • K915316Aap Bone ScrewAap International, Ltd. · 1992

All 2 as Aap International, Ltd. →