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SS Innovations submitted its response on Oct. 5, 2026 to an FDA request tied to its SSi Mantra 510(k) filing. Results have already been provided to the FDA, including final data from an expanded human clinical and human-factors validation study. The submission also included final data from a bridging study completed in
SS Innovations submitted its response to an FDA request for additional information on its 510(k) filing for the SSi Mantra. The package includes final data from expanded human clinical and human factors validation work, plus a bridging study completed in August 2026. FDA review of the response and the 510(k) is expecte
SS Innovations submitted a response to an FDA request for additional information regarding its 510(k) submission for the SSi Mantra.