STAINLESS STEEL SOFT SUTURE WIRE— 510(k) K990355

Substantially Equivalent

Bregma International Trading Company , Ltd.

FDA 510(k) clearance K990355 for STAINLESS STEEL SOFT SUTURE WIRE, Substantially Equivalent on 1999-07-08. Applicant: Bregma International Trading Company , Ltd..

Clearance details

Applicant: Bregma International Trading Company , Ltd.
Product code: Code LRN
Advisory panel: Orthopedic
Date received: 1999-02-05
Decision date: 1999-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saskatoon, Saskatchewan, CA

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Adverse events under product code LRN

product code LRN

Injury: 185
Total: 185

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.