PRECISION SCREW DRIVER SET— 510(k) K872389

Substantially Equivalent

Med-Tool, Inc.

FDA 510(k) clearance K872389 for PRECISION SCREW DRIVER SET, Substantially Equivalent on 1987-07-15. Applicant: Med-Tool, Inc..

Clearance details

Applicant: Med-Tool, Inc.
Product code: Code HXX
Advisory panel: Orthopedic
Date received: 1987-06-19
Decision date: 1987-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code HXX

product code HXX

Injury: 471
Malfunction: 10,945
Total: 11,416

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.