510(k) Report

FDA applicant

Bregma International Trading Company, Ltd.

Saskatoon, Saskatchewan, CA3 decisions1999–19990 recalls

FDA records 3 decisions for Bregma International Trading Company, Ltd. (Saskatoon, Saskatchewan, CA) in 1999: 3 510(k) clearances. Most are in product codes JDW (Pin, Fixation, Threaded) 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 Bregma International Trading Company, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bregma International Trading Company, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bregma International Trading Company, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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