Cleared Traditional

K132639 - CD HORIZON SPINAL SYSTEM

K132639 is the FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K132639 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Nov 2013
Decision
94d
Days
Class 2
Risk

K132639 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on November 25, 2013 after a review of 94 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K132639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2013
Decision Date November 25, 2013
Days to Decision 94 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K132639.
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291 · Zimmer Spine, Inc. · Dec 2013
CD HORIZON SPINAL SYSTEM
K132328 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · Zimmer Spine, Inc. · Nov 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884 · Zimmer Spine, Inc. · Nov 2013
GSB GLOBAL SPINAL BALANCE SYSTEM
K132014 · Nuvasive, Inc. · Oct 2013
NAUTILUS SPINAL SYSTEM
K132866 · Life Spine, Inc. · Oct 2013