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FDA 510(k)

SOVEREIGN® Spinal System

K-Number: K162680 · 2016-12-14

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2016-12-14
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K162680. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOVEREIGN® Spinal System?

SOVEREIGN® Spinal System is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K162680.

When did SOVEREIGN® Spinal System receive FDA 510(k) clearance?

SOVEREIGN® Spinal System received FDA 510(k) clearance on 2016-12-14, under 510(k) number K162680.

Who is the listed applicant for SOVEREIGN® Spinal System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOVEREIGN® Spinal System?

The FDA product code for SOVEREIGN® Spinal System is OVD.

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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.

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