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
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical robotic procedures including cardiac surgery. Headquartered in India, SS Innovations is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.
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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