MICROPOWER HAND PIECE HIGH SPEED DRILL— 510(k) K060260

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K060260 for MICROPOWER HAND PIECE HIGH SPEED DRILL, Substantially Equivalent on 2006-04-10. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code HBC
Advisory panel: Neurology
Date received: 2006-02-01
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Largo, FL, US

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Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.