CD HORIZON Spinal System— 510(k) K203678

Name: FDA 510(k) clearance K203678
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K203678 for CD HORIZON Spinal System, Substantially Equivalent on 2021-01-15. 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: 2020-12-17
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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