CD Horizon Spinal System
K-Number: K211958 · 2021-07-21
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2021-07-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CD Horizon Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2021-07-21 under approval number K211958. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CD Horizon Spinal System?
CD Horizon Spinal System is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K211958.
When was CD Horizon Spinal System approved by the FDA?
CD Horizon Spinal System received FDA 510(k) clearance on 2021-07-21, under approval number K211958.
What company makes CD Horizon Spinal System?
CD Horizon Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for CD Horizon Spinal System?
The FDA product code for CD Horizon Spinal System is NKB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.