---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-118977"
form_type: "8-K"
ticker: "SSII"
cik: "0001676163"
company_name: "SS Innovations International, Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T13:58:59.906802+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# SS Innovations submits 510(k) to FDA for SSi Mantra surgical robot; installed base reaches 138 systems

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-118977
- form_type: 8-K
- ticker: SSII
- cik: 0001676163
- company_name: SS Innovations International, Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1676163/000121390025118977/0001213900-25-118977-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1676163/000121390025118977/ea0268739-8k_ssinno.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-118977
- JSON: https://secwatch.observer/filing/0001213900-25-118977.json
- Plain text: https://secwatch.observer/filing/0001213900-25-118977.txt

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