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CAUTION: Investigational devices. The ONSS and iSPGS systems are investigational devices and are not approved or cleared for commercial use in any market. In the United States: CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use. In the European Union: Exclusively for clinical investigation under Regulation (EU) 2017/745 (MDR). FDA Breakthrough Device Designation does not constitute FDA clearance, approval, or marketing authorization.