Cleared Traditional

K002523 - ADVANTAGE DRIVE SYSTEM

K002523 is an FDA 510(k) clearance for ADVANTAGE DRIVE SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K002523 · Linvatec Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
52d
Days
Class 2
Risk

K002523 is an FDA 510(k) clearance for the ADVANTAGE DRIVE SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on October 6, 2000 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002523

510(k) Number K002523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date October 06, 2000
Days to Decision 52 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
97d faster than avg
Panel avg: 149d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBC Motor, Drill, Electric

All 26
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K002523.
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
K012457 · Sodemsystems · Oct 2001
ANSPACH EMAX DRILL SYSTEM
K011444 · The Anspach Effort, Inc. · Aug 2001
MICROSPEED EC MOTORSYSTEM GD650/GD653
K003612 · Aesculap, Inc. · Feb 2001
SERVOTRONIC EC100 SYSTEM
K972857 · Medicon EG · Jan 1998
SURGICAL DRILL (ELECTRIC) INCLUDING HANDPIECE
K862989 · Entronics · Aug 1986
450/800 DRILL
K812436 · Black & Decker(Tm) · Nov 1981
K002523 · ADVANTAGE DRIVE SYSTEM
Download PDF FDA Summary Linvatec Corp.