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 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 2018-10-04 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182436.

When did POWEREASE System receive FDA 510(k) clearance?

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

Who is the listed applicant for POWEREASE 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 POWEREASE System?

The FDA product code for POWEREASE System is HBE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.