{"id":"f6bd8f6d-bfcd-4e1d-9e1a-5232750208e8","slug":"ssi-mantra-fda-510k-submission","filingNumber":null,"filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":null,"filingDate":null,"decisionDate":"2025-12-05T00:00:00.000Z","status":"pending","clearanceScope":"SS Innovations submitted 510(k) premarket notification to FDA on December 5, 2025 for SSi Mantra surgical robotic system. Changed course from De Novo to 510(k) pathway. Expects clearance in Q4.","sources":[{"url":"https://www.medtechdive.com/news/SS-Innovations-surgical-robot-FDA-submission/801859/","title":"MedTech Dive: SS Innovations changes FDA course"}],"verificationPosture":null,"capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-18T12:44:59.582Z","updatedAt":"2026-07-18T12:44:59.582Z","applicantCompany":null,"modelLinks":[{"id":"de316b89-f834-41a7-ae4d-6b1f79ca3d18","modelId":"2cd2961a-8f57-487b-a5e4-faae826ff59f","regulatoryFilingId":"f6bd8f6d-bfcd-4e1d-9e1a-5232750208e8","createdAt":"2026-07-18T12:44:59.963Z","model":{"slug":"ssi-mantra","modelName":"SSi Mantra"}}]}