Regulatory filing

fda_510k (us_fda)

SS Innovations submitted 510(k) premarket notification to FDA on December 5, 2025 for SSi Mantra surgical robotic system. Changed course from De Novo to 510(k) pathway. Expects clearance in Q4.

fda 510k · pending · decided 2025-12-05

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: pending
Decision date: 2025-12-05

Covered models (1)

SSi Mantra

Sources (1)

https://www.medtechdive.com/news/SS-Innovations-surgical-robot-FDA-submission/801859/

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Identity

f6bd8f6d-bfcd-4e1d-9e1a-5232750208e8