BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS— 510(k) K130614

Substantially Equivalent

Laura Cattabriga

FDA 510(k) clearance K130614 for BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS, Substantially Equivalent on 2014-01-17. Applicant: Laura Cattabriga.

Clearance details

Applicant: Laura Cattabriga
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2013-03-07
Decision date: 2014-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Bay Village, FL, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.