STAINLESS STEEL FIXATION PINS— 510(k) K990353

Substantially Equivalent

Bregma International Trading Company , Ltd.

FDA 510(k) clearance K990353 for STAINLESS STEEL FIXATION PINS, Substantially Equivalent on 1999-06-01. Applicant: Bregma International Trading Company , Ltd..

Clearance details

Applicant: Bregma International Trading Company , Ltd.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 1999-02-05
Decision date: 1999-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saskatoon, Saskatchewan, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.