Cleared Traditional

K984360 - COLORADO II SPINAL SYSTEM

K984360 is an FDA 510(k) clearance for COLORADO II SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 479-day FDA review.

K984360 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
479d
Days
Class 2
Risk

K984360 is an FDA 510(k) clearance for the COLORADO II SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on March 30, 2000 after a review of 479 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K984360

510(k) Number K984360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1998
Decision Date March 30, 2000
Days to Decision 479 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
357d slower than avg
Panel avg: 122d · This submission: 479d
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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K984360.
PASS SPINAL SYSTEM
K001024 · Encore Orthopedics, Inc. · May 2000
XIA SPINE SYSTEM HOOKS
K001319 · Howmedica Osteonics Corp. · May 2000
COLORADO II SPINAL SYSTEM
K991031 · Sofamor Danek USA,Inc. · May 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · Medtronic Sofamor Danek, Inc. · Mar 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · Medtronic Sofamor Danek, Inc. · Mar 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · Blackstone Medical, Inc. · Feb 2000