Cleared Traditional

K101168 - LEGEND POWER ADAPTER MODEL: 6475000

K101168 is an FDA 510(k) clearance for LEGEND POWER ADAPTER MODEL: 6475000, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K101168 · Medtronic Sofamor Danek · Neurology device
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Aug 2010
Decision
120d
Days
Class 2
Risk

K101168 is an FDA 510(k) clearance for the LEGEND POWER ADAPTER MODEL: 6475000. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 24, 2010 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K101168

510(k) Number K101168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2010
Decision Date August 24, 2010
Days to Decision 120 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 148d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 22
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K101168.
ELAN 4 Air Motor System
K172907 · Aesculap, Inc. · Nov 2018
Medtronic Legend Pneumatic
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Stryker Maestro Air Motors
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SYNTHES AIR PEN DRIVE (APD) SYSTEM
K093361 · Synthes (Usa) · Apr 2010
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297 · The Anspach Effort, Inc. · Jan 2007
STRYKER ARIA PNEUMATIC SYSTEM
K061725 · Stryker Instruments · Oct 2006