K853762

Substantially Equivalent

ISOMETRIC ACL DRILL GUIDE

Applicant: Orthopedic Systems, Inc.
Product code: GEY
Advisory panel: General, Plastic Surgery
Date received: 1985-09-09
Decision date: 1985-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.