ISOMETRIC ACL DRILL GUIDE— 510(k) K853762

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K853762 for ISOMETRIC ACL DRILL GUIDE, Substantially Equivalent on 1985-10-07. Applicant: Orthopedic Systems, Inc..

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: 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

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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.