FDA 510(k)

Capstone Control Spinal System

K-Number: K190165 · 2019-05-06

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2019-05-06

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Capstone Control Spinal System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-05-06 under approval number K190165. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capstone Control Spinal System?

Capstone Control Spinal System is a medical device that received FDA 510(k) clearance on 2019-05-06. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K190165.

When was Capstone Control Spinal System approved by the FDA?

Capstone Control Spinal System received FDA 510(k) clearance on 2019-05-06, under approval number K190165.

What company makes Capstone Control Spinal System?

Capstone Control Spinal System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for Capstone Control Spinal System?

The FDA product code for Capstone Control Spinal System is MAX.

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Other Devices by Medtronic Sofamor Danek USA, Inc.

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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.