SS Innovations completes human factors validation study for SSi Mantra; plans FDA 510(k) in Q4 2025

SS Innovations International, Inc.

Completed human factors validation study for SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025.
Anticipates submitting 510(k) premarket notification to FDA in Q4 2025; potential US clearance in H1 2026 if FDA approves.
Company pivoted from De Novo request to 510(k) pathway for speed and cost advantages per FDA discussions.
SSi Mantra cumulative installed base: 125 systems across 6 countries; 119 hospitals, over 6,000 procedures performed.

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