CD Horizon Astute Spinal System— 510(k) K191066

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K191066 for CD Horizon Astute Spinal System, Substantially Equivalent on 2019-10-03. Applicant: Medtronic Sofamor Danek USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code NQP
Advisory panel: Orthopedic
Date received: 2019-04-22
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

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