Cleared Special

K130497 - D4000 DRIVE SYSTEM (FDA 510(k) Clearance)

Also includes:
D4000A DRIVE SYSTEM WITH IRRIGATION

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130497 · Linvatec Corporation D/B/A Conmed Linvatec · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
31d
Days
Class 2
Risk

K130497 is an FDA 510(k) clearance for the D4000 DRIVE SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Linvatec Corporation D/B/A Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on March 29, 2013 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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.

View all Linvatec Corporation D/B/A Conmed Linvatec devices

Submission Details

510(k) Number K130497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2013
Decision Date March 29, 2013
Days to Decision 31 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 148d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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.