Cleared Special

K043343 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM

K043343 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 MNH) cleared through the Special 510(k) pathway after a 22-day FDA review.

K043343 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2004
Decision
22d
Days
Class 2
Risk

K043343 is an FDA 510(k) clearance for the MODIFICATION TO: CD HORIZON SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 28, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 K043343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date December 28, 2004
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K043343.
NUVASIVE SPHERX SYSTEM
K060225 · Nuvasive, Inc. · Apr 2006
XIA 4.5 SPINAL SYSTEM
K050461 · Stryker Spine · Jul 2005
STRYKER SPINE TRIO PS
K043180 · Stryker Spine · Mar 2005
PROTEX STABILIZATION SYSTEM
K040442 · Globus Medical, Inc. · May 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · Medtronic Sofamor Danek · Apr 2004
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004