OSTEOMILL BONE GRINDER— 510(k) K861164

Substantially Equivalent

Biodynamic Technologies, Inc.

FDA 510(k) clearance K861164 for OSTEOMILL BONE GRINDER, Substantially Equivalent on 1986-05-02. Applicant: Biodynamic Technologies, Inc..

Clearance details

Applicant: Biodynamic Technologies, Inc.
Product code: Code LYS
Advisory panel: Orthopedic
Date received: 1986-03-28
Decision date: 1986-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

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Adverse events under product code LYS

product code LYS

Malfunction: 1,152
Total: 1,152

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.