SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)— 510(k) K111437

Substantially Equivalent

Synthes (USA) Products, LLC

FDA 510(k) clearance K111437 for SYNTHES RIA SYSTEM (EXPANDED INDICATIONS), Substantially Equivalent on 2011-08-10. Applicant: Synthes (USA) Products, LLC.

Clearance details

Applicant: Synthes (USA) Products, LLC
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 2011-05-24
Decision date: 2011-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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Adverse events under product code HTO

product code HTO

Injury: 404
Malfunction: 20,305
Total: 20,709

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.