{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-095851","form_type":"8-K","ticker":"SSII","cik":"0001676163","company_name":"SS Innovations International, Inc.","filed_at":"2025-10-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.119932+00:00","generated_at":"2026-05-17T04:46:40.277112+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"SS Innovations completes human factors validation study for SSi Mantra; plans FDA 510(k) in Q4 2025","bullets":["Completed human factors validation study for SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025.","Anticipates submitting 510(k) premarket notification to FDA in Q4 2025; potential US clearance in H1 2026 if FDA approves.","Company pivoted from De Novo request to 510(k) pathway for speed and cost advantages per FDA discussions.","SSi Mantra cumulative installed base: 125 systems across 6 countries; 119 hospitals, over 6,000 procedures performed."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-095851","json":"https://secwatch.observer/filing/0001213900-25-095851.json","markdown":"https://secwatch.observer/filing/0001213900-25-095851.md","text":"https://secwatch.observer/filing/0001213900-25-095851.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676163/000121390025095851/0001213900-25-095851-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676163/000121390025095851/ea0260185-8k_ssinnova.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T04:46:40.277112+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}