SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION— 510(k) K860600

Substantially Equivalent

3M Company

FDA 510(k) clearance K860600 for SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION, Substantially Equivalent on 1986-03-13. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1986-02-19
Decision date: 1986-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.