HELENA SYSTEM— 510(k) K110177

Name: FDA 510(k) clearance K110177
Creator: U.S. Food and Drug Administration
Published: 2011-04-21

Substantially Equivalent

Royal Oak Medical Devices

FDA 510(k) clearance K110177 for HELENA SYSTEM, Substantially Equivalent on 2011-04-21. Applicant: Royal Oak Medical Devices. Device class: 2.

Clearance details

Applicant: Royal Oak Medical Devices
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-01-21
Decision date: 2011-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomfield Hills, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.