Cleared Special

K020709 - MODIFICATION TO CD HORIZON SPINAL SYSTEM

K020709 is the FDA 510(k) clearance for MODIFICATION TO CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 65-day FDA review.

K020709 · Medtronic Sofamor Danek · Orthopedic device
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May 2002
Decision
65d
Days
Class 2
Risk

K020709 is an FDA 510(k) clearance for the MODIFICATION TO CD HORIZON SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on May 9, 2002 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K020709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date May 09, 2002
Days to Decision 65 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K020709.
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · Medtronic Sofamor Danek, Inc. · Jul 2002
TSRH SPINAL SYSTEM
K021170 · Medtronic Sofamor Danek USA, Inc. · Jul 2002
OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM
K021009 · Spinal Concepts, Inc. · Jun 2002
SPIRAL RADIUS 90-D RODDING SYSTEM
K020134 · United States Surgical, A Division of Tyco Healthc · Apr 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090 · Endius, Inc. · Mar 2002
MSD WIRE SYSTEM
K020426 · Medtronic Sofamor Danek, Inc. · Feb 2002