Cleared Special

K034056 - MODIFICATION TO CD HORIZON SPINAL SYSTEM

K034056 is an FDA 510(k) clearance for MODIFICATION TO CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 113-day FDA review.

K034056 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
113d
Days
Class 2
Risk

K034056 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 April 21, 2004 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K034056

510(k) Number K034056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date April 21, 2004
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K034056.
ALADYN RIGID SPINE PLATE
K040747 · Scient'X · Jun 2004
PROCYON SPINAL SYSTEM
K033512 · Nas Medical Technologies, Inc. · Jun 2004
PROTEX STABILIZATION SYSTEM
K040442 · Globus Medical, Inc. · May 2004
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · Medtronic Sofamor Danek, Inc. · Feb 2004
GII SPINAL FIXATION SYSTEM
K032604 · Co-Ligne AG · Jan 2004
K034056 · MODIFICATION TO CD HORIZON SPINAL SYSTEM
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