3M OSTEOTOMY GUIDE— 510(k) K830360

Substantially Equivalent

3M Company

FDA 510(k) clearance K830360 for 3M OSTEOTOMY GUIDE, Substantially Equivalent on 1983-03-01. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code HWT
Advisory panel: Orthopedic
Date received: 1983-02-03
Decision date: 1983-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White City, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWT

product code HWT

Injury: 218
Malfunction: 12,907
Total: 13,125

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.