---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-040839"
form_type: "8-K"
ticker: "SSII"
cik: "0001676163"
company_name: "SS Innovations International, Inc."
filed_at: "2025-05-08T23:59:59+00:00"
generated_at: "2026-05-22T04:47:54.674309+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# SS Innovations plans FDA De Novo submission for SSi Mantra 3 in July 2025

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-040839
- form_type: 8-K
- ticker: SSII
- cik: 0001676163
- company_name: SS Innovations International, Inc.
- filed_at: 2025-05-08T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676163/000121390025040839/0001213900-25-040839-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676163/000121390025040839/ea0241392-8k_ssinnov.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-040839
- JSON: https://secwatch.observer/filing/0001213900-25-040839.json
- Plain text: https://secwatch.observer/filing/0001213900-25-040839.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.