{"id":"bf43e8d7-47b5-474c-bab8-d0ed5e428980","slug":"lem-surgical-dynamis-fda-510k","filingNumber":"K243326","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":null,"filingDate":null,"decisionDate":"2025-04-23T00:00:00.000Z","status":"cleared","clearanceScope":"LEM Surgical Dynamis robotic surgical system FDA 510(k) clearance. Integrated navigation-based robotic platform with real-time tracking for spine surgical procedures. Second clearance adds individual vertebra tracking, stabilization, and cervical indications.","sources":[{"url":"https://www.massdevice.com/lem-surgical-new-fda-clearance-surgical-robot/","title":"LEM Surgical wins new FDA clearance for humanoid surgical robot"}],"verificationPosture":null,"capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-18T02:41:35.567Z","updatedAt":"2026-07-18T02:41:35.567Z","applicantCompany":null,"modelLinks":[{"id":"ec9fcd5b-9dfa-4966-8d5f-a81d7f1a0b23","modelId":"f6026d6b-7905-493a-b441-b864fc7fd0fd","regulatoryFilingId":"bf43e8d7-47b5-474c-bab8-d0ed5e428980","createdAt":"2026-07-18T02:41:35.939Z","model":{"slug":"lem-surgical-dynamis","modelName":"Dynamis"}}]}