Cleared Traditional

K050809 - CD HORIZON SPINAL SYSTEM

K050809 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 KWP) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K050809 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
75d
Days
Class 2
Risk

K050809 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 14, 2005 after a review of 75 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. 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 USA, Inc. devices

Submission Details

510(k) Number K050809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date June 14, 2005
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K050809.
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · Stryker Spine · Aug 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · Globus Medical, Inc. · Jul 2005
BASIS SPINAL SYSTEM
K050484 · Medtronic Sofamor Danek, Inc. · May 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · Medtronic Sofamor Danek · Apr 2005
TECHTONIX SYSTEM
K050189 · Stryker Spine · Feb 2005