ARTHROBOT(TM) LOWER LIMB POSITIONER— 510(k) K880227

Name: FDA 510(k) clearance K880227
Creator: U.S. Food and Drug Administration
Published: 1988-02-18

Substantially Equivalent

Andronic Devices, Ltd.

FDA 510(k) clearance K880227 for ARTHROBOT(TM) LOWER LIMB POSITIONER, Substantially Equivalent on 1988-02-18. Applicant: Andronic Devices, Ltd.. Device class: 1.

Clearance details

Applicant: Andronic Devices, Ltd.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1988-01-20
Decision date: 1988-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.