MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM— 510(k) K013527

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K013527 for MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM, Substantially Equivalent on 2001-12-21. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code HTO
Advisory panel: Orthopedic
Date received: 2001-10-23
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Paoli, 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.