secwatch.observer — SEC 8-K summary
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Issuer:     SS Innovations International, Inc. (SSII)
CIK:        0001676163
Form:       8-K
Filed at:   2025-12-08T23:59:59+00:00
Accession:  0001213900-25-118977
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

SS Innovations submits 510(k) to FDA for SSi Mantra surgical robot; installed base reaches 138 systems
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- Submitted 510(k) premarket notification to FDA on Dec 5, 2025 for SSi Mantra system covering general, urological, colorectal, gynecological, and cardiac surgeries.
- EU CE marking certification expected in first half of 2026.
- Cumulative installed base of 138 systems across 8 countries; 7,300+ procedures performed including 88 telesurgeries and 390 cardiac.
- FDA targets 90-day review cycle for 510(k) submissions; actual approval timing may vary.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676163/000121390025118977/0001213900-25-118977-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676163/000121390025118977/ea0268739-8k_ssinno.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-118977

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