secwatch.observer — SEC 8-K summary
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Issuer:     SS Innovations International, Inc. (SSII)
CIK:        0001676163
Form:       8-K
Filed at:   2025-05-08T23:59:59+00:00
Accession:  0001213900-25-040839
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

SS Innovations plans FDA De Novo submission for SSi Mantra 3 in July 2025
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- Planned De Novo Classification Request to FDA in July 2025 for multispecialty indications including urology, gynecology, general surgery, thoracic and cardiac.
- 80 SSi Mantra systems installed in 75 hospitals since August 2022; over 3,800 surgeries performed, including 200 robotic cardiac.
- SSi Mantra 3 launched June 2024; 37 systems installed with over 750 procedures (70 cardiac) and no device-related mortality or complications.
- Clinical data validated by a leading third-party CRO for safety, feasibility and efficacy.
- Company holds approvals in seven countries and is also pursuing European CE Mark approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676163/000121390025040839/0001213900-25-040839-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676163/000121390025040839/ea0241392-8k_ssinnov.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-040839

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer