DRILL BIT— 510(k) K841629

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841629 for DRILL BIT, Substantially Equivalent on 1984-08-27. Applicant: Plastafil, Inc..

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HTW
Advisory panel: Orthopedic
Date received: 1984-04-19
Decision date: 1984-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.