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FDA 510(k)

POWEREASE System

K-Number: K182436 · 2018-10-04

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-10-04
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POWEREASE System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-10-04 under approval number K182436. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWEREASE System?

POWEREASE System is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182436.

When was POWEREASE System approved by the FDA?

POWEREASE System received FDA 510(k) clearance on 2018-10-04, under approval number K182436.

What company makes POWEREASE System?

POWEREASE System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for POWEREASE System?

The FDA product code for POWEREASE System is HBE.

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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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