CD Horizon Astute Spinal System— 510(k) K191066

Name: FDA 510(k) clearance K191066
Creator: U.S. Food and Drug Administration
Published: 2019-10-03

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.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code NQP
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2019-04-22
Decision date: 2019-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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