{"id":"8a29ffa5-1b3b-4737-ba1b-cda8760297b8","slug":"mazor-x-fda-510k","filingNumber":"K251316","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"5ed6adff-c714-4880-bb1e-62af35017f4f","filingDate":"2018-11-01T00:00:00.000Z","decisionDate":"2018-11-01T00:00:00.000Z","status":"cleared","clearanceScope":"FDA 510(k) for Mazor X Stealth robotic-assisted spinal surgery system. Original clearance Nov 2018. K251316 is software enhancement. SpineAssist (2004) was first FDA-approved robotic spine surgery platform.","sources":[{"url":"https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251316.pdf","title":"K251316 510(k)","sourceName":"FDA"},{"url":"https://www.therobotreport.com/mazor-x-stealth-spinal-us/","title":"Mazor X Stealth launches in US","sourceName":"The Robot Report"}],"verificationPosture":"verified","capFlagNotes":"Multiple clearances. Original 2018, enhancement K251316.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:28:31.301Z","updatedAt":"2026-07-15T02:28:31.301Z","applicantCompany":{"id":"5ed6adff-c714-4880-bb1e-62af35017f4f","slug":"medtronic","name":"Medtronic"},"modelLinks":[{"id":"171eb378-8a2e-4006-8390-dbe86396ee5e","modelId":"87637564-f3b6-4eaf-8aa9-32d5879d3c9c","regulatoryFilingId":"8a29ffa5-1b3b-4737-ba1b-cda8760297b8","createdAt":"2026-07-15T02:28:32.177Z","model":{"slug":"mazor-robotics-mazor-x","modelName":"Mazor X"}}]}