{"id":"72032331-aa9d-43ac-b137-e8c36ee7251e","slug":"zimmer-biomet-rosa-fda-510k","filingNumber":null,"filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","filingDate":"2019-01-01T00:00:00.000Z","decisionDate":"2019-06-01T00:00:00.000Z","status":"cleared","clearanceScope":"FDA 510(k) for ROSA Knee (2019), Hip (2021), ONE Brain (Feb 2019), Shoulder (2024). ROSA-Brain recall (2021, Class I).","sources":[{"url":"https://www.zimmerbiomet.com/","title":"Zimmer Biomet","sourceName":"Zimmer Biomet"}],"verificationPosture":"verified","capFlagNotes":"Multiple clearances across indications. Class I recall.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:26:27.106Z","updatedAt":"2026-07-15T02:26:27.106Z","applicantCompany":{"id":"bf360924-7c7c-4b17-8fcf-8abf5950c0ff","slug":"zimmer-biomet","name":"Zimmer Biomet"},"modelLinks":[{"id":"38017582-240e-498a-a329-ae93c12912a8","modelId":"deb70c72-adc4-4912-b3f3-cddee712e118","regulatoryFilingId":"72032331-aa9d-43ac-b137-e8c36ee7251e","createdAt":"2026-07-15T02:26:27.956Z","model":{"slug":"zimmer-biomet-rosa","modelName":"ROSA"}}]}