Cleared Special

K182436 - POWEREASE System

K182436 is an FDA 510(k) clearance for POWEREASE System, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Neurology device with product code HBE cleared through the Special 510(k) pathway after a 27-day FDA review.

K182436 · Medtronic Sofamor Danek USA, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
27d
Days
Class 2
Risk

K182436 is an FDA 510(k) clearance for the POWEREASE System. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 4, 2018 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K182436

510(k) Number K182436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2018
Decision Date October 04, 2018
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 149d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

HBE Device Classification - Class 2, Special Controls

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 64
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K182436 · POWEREASE System
Download PDF FDA Summary Medtronic Sofamor Dan…