Cleared Special

MODIFICATION TO CD HORIZON SPINAL SYSTEM (K000094) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K000094 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
26d
Days
Class 2
Risk

K000094 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 USA, Inc. (Memphis, US). The FDA issued a Cleared decision on February 8, 2000 after a review of 26 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 USA, Inc. devices

Submission Details

510(k) Number K000094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2000
Decision Date February 08, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K000094.
OSTEONICS SPINAL SYSTEM
K020293 · Howmedica Osteonics Corp. · Feb 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · Howmedica Osteonics Corp. · Jan 2002
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · Howmedica Osteonics Corp. · Dec 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · United States Surgical, A Division of Tyco Healthc · Aug 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · Howmedica Osteonics Corp. · Apr 2001
SOCON SPINAL SYSTEM
K003463 · Aesculap, Inc. · Apr 2001