{"id":"3f698db3-9791-423e-a474-6172bf458028","slug":"ssi-mantra-fda-510k-pending","filingNumber":null,"filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"d379bc4f-a144-46c8-8c2a-17554ab559e1","filingDate":"2025-12-08T00:00:00.000Z","decisionDate":null,"status":"pending","clearanceScope":"SS Innovations submitted 510(k) for SSi Mantra Surgical Robotic System to FDA Dec 8, 2025. Pivoted from De Novo to 510(k) pathway.","sources":[{"url":"https://finance.yahoo.com/news/ss-innovations-submits-510-k-133000188.html","title":"SS Innovations Submits 510(k) for SSi Mantra","sourceName":"Yahoo Finance"}],"verificationPosture":"verified","capFlagNotes":"Pending review. Pivoted from De Novo to 510(k).","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:28:34.784Z","updatedAt":"2026-07-15T02:28:34.784Z","applicantCompany":{"id":"d379bc4f-a144-46c8-8c2a-17554ab559e1","slug":"ss-innovations","name":"SS Innovations International"},"modelLinks":[{"id":"c124d0f3-efa4-407b-a3a4-35827358e294","modelId":"2cd2961a-8f57-487b-a5e4-faae826ff59f","regulatoryFilingId":"3f698db3-9791-423e-a474-6172bf458028","createdAt":"2026-07-15T02:28:35.657Z","model":{"slug":"ssi-mantra","modelName":"SSi Mantra"}}]}