Cleared Traditional

K000641 - CD HORIZON SPINAL SYSTEM

K000641 is an FDA 510(k) clearance for CD HORIZON SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K000641 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Dec 2000
Decision
301d
Days
Class 2
Risk

K000641 is an FDA 510(k) clearance for the CD HORIZON SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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, Inc. devices

FDA 510(k) Submission Details - K000641

510(k) Number K000641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2000
Decision Date December 22, 2000
Days to Decision 301 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
179d slower than avg
Panel avg: 122d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 255
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K000641.
TRIFIX SPINAL FIXATION SYSTEM
K010535 · Endius, Inc. · Mar 2001
CD HORIZON SPINAL SYSTEM
K010249 · Medtronic Sofamor Danek, Inc. · Feb 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · Ebi, L.P. · Jan 2001
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
VERSALINK TITANIUM ROD-TO-ROD COUPLERS
K003384 · Osteotech, Inc. · Nov 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · Medtronic Sofamor Danek, Inc. · Sep 2000