Cleared Traditional

K043602 - QUADRANT RETRACTOR SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K043602 · Medtronic Sofamor Danek · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
56d
Days
Class 1
Risk

K043602 is an FDA 510(k) clearance for the QUADRANT RETRACTOR SYSTEM. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on February 23, 2005 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K043602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date February 23, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 114d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.