{"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","discovered_at":"2026-05-14T18:02:40.121402+00:00","generated_at":"2026-05-16T13:58:59.906802+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"SS Innovations submits 510(k) to FDA for SSi Mantra surgical robot; installed base reaches 138 systems","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-118977","json":"https://secwatch.observer/filing/0001213900-25-118977.json","markdown":"https://secwatch.observer/filing/0001213900-25-118977.md","text":"https://secwatch.observer/filing/0001213900-25-118977.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:58:59.906802+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"}