OTI EUROPEAN COMPRESSION SYSTEM— 510(k) K925571

Substantially Equivalent

Osteo-Technology Intl., Inc.

FDA 510(k) clearance K925571 for OTI EUROPEAN COMPRESSION SYSTEM, Substantially Equivalent on 1993-07-13. Applicant: Osteo-Technology Intl., Inc..

Clearance details

Applicant: Osteo-Technology Intl., Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1992-11-03
Decision date: 1993-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timonium, MD, US

Download summary PDF View on FDA.gov ↗

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.