TORQUEDRIVER WRENCH— 510(k) K870053

Substantially Equivalent

Jerome Medical

FDA 510(k) clearance K870053 for TORQUEDRIVER WRENCH, Substantially Equivalent on 1987-03-11. Applicant: Jerome Medical.

Clearance details

Applicant: Jerome Medical
Product code: Code HXC
Advisory panel: Orthopedic
Date received: 1987-01-07
Decision date: 1987-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Laurel, NJ, US

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Adverse events under product code HXC

product code HXC

Malfunction: 851
Total: 851

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.