Cleared Special

K030875 - MODIFICATION TO COLORADO 2 SPINAL SYSTEM

K030875 is the FDA 510(k) clearance for MODIFICATION TO COLORADO 2 SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 96-day FDA review.

K030875 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Jun 2003
Decision
96d
Days
Class 2
Risk

K030875 is an FDA 510(k) clearance for the MODIFICATION TO COLORADO 2 SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 24, 2003 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Standard predicate reliance. 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, Inc. devices

Submission Details

510(k) Number K030875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2003
Decision Date June 24, 2003
Days to Decision 96 days
Submission Type Special
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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

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
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