BONE PLUGGING TOOL— 510(k) K834229

Substantially Equivalent

Standard Surgical

FDA 510(k) clearance K834229 for BONE PLUGGING TOOL, Substantially Equivalent on 1984-01-10. Applicant: Standard Surgical.

Clearance details

Applicant: Standard Surgical
Product code: Code HTW
Advisory panel: Orthopedic
Date received: 1983-12-06
Decision date: 1984-01-10
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.