ROTH-KENNEDY PASSER— 510(k) K791960

Substantially Equivalent

3M Company

FDA 510(k) clearance K791960 for ROTH-KENNEDY PASSER, Substantially Equivalent on 1979-10-04. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code HWQ
Advisory panel: Orthopedic
Date received: 1979-10-01
Decision date: 1979-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White City, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWQ

product code HWQ

Injury: 137
Malfunction: 443
Total: 580

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.