MALLET— 510(k) K841627

Substantially Equivalent

Plastafil, Inc.

FDA 510(k) clearance K841627 for MALLET, Substantially Equivalent on 1984-08-27. Applicant: Plastafil, Inc..

Clearance details

Applicant: Plastafil, Inc.
Product code: Code HWA
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 HWA

product code HWA

Malfunction: 12,146
Other: 2
Total: 12,148

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.