Common Stock
- Symbol
- SSII
- Exchange
- NASDAQ
- Classification
- COMMON
Current Report · Items 8.01, 9.01 · 8-K
SS Innovations International Inc.
SSIINASDAQEQUITYCurrent
Other Events
Item 8.01 Other Events. On October 13, 2026, SSi issued a press release announcing that, on October 5, 2026, the Company submitted its response to a request for additional information letter received from the United States Food and Drug Administration with respect to its 510(k) application for SSi’s SSi Mantra surgical robotic system. A copy of the press release is included as Exhibit 99.1 to this Current Report.
Company context
We are a commercial-stage surgical robotics company focused on transforming patient lives by democratizing access to advanced surgical robotics technologies. We design, manufacture and market an advanced, next-generation and affordable surgical robotic system called the SSi Mantra Surgical Robotic System (the “SSi Mantra”) intended for use in urology, general, gynecology, colorectal, gastroenterology, head and neck, thoracic and cardiac surgeries. While surgical robotic systems have gained acceptance globally in the past two decades for providing greater efficiency, better clinical outcomes and reducing healthcare costs, access to such systems remains largely limited to developed countries such as the United States (the “U.S.”), the European Union (the “EU”) and Japan. With the SSi Mantra, we are breaking down barriers and accelerating access to surgical robotics technologies in underserved regions of the world.
Current securities
Registered securities in this filing
SS INNOVATIONS INTERNATIONAL, INC. · 8-K · Filed 2026-10-13
Disclosure sections
Item 8.01Item 8.01 - Other Events
Item
8.01 Other Events.
On
October 13, 2026, SSi issued a press release announcing that, on October 5, 2026, the Company submitted its response to a request for
additional information letter received from the United States Food and Drug Administration with respect to its 510(k) application for
SSi’s SSi Mantra surgical robotic system.
A
copy of the press release is included as Exhibit 99.1 to this Current Report.
Filed exhibits (1)
Exhibit 99.1 SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra FORT LAUDERDALE, Fla. - October 13, 2026 - SS Innovations International, Inc. (the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the “ AINN ”) received from the United States Food and Drug Administration (the “ FDA ”) with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the “ SSi Mantra ”). The Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the “ Study ”) for the SSi Mantra. The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification. The Company’s response to the AINN also includes final data …
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