Cleared Traditional

K062447 - TRAVERSE OCT SPINAL FIXATION SYSTEM

K062447 is the FDA 510(k) clearance for TRAVERSE OCT SPINAL FIXATION SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 419-day FDA review.

K062447 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
419d
Days
Class 2
Risk

K062447 is an FDA 510(k) clearance for the TRAVERSE OCT SPINAL FIXATION 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 October 15, 2007 after a review of 419 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K062447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2006
Decision Date October 15, 2007
Days to Decision 419 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
297d slower than avg
Panel avg: 122d · This submission: 419d
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 K062447.
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · Blackstone Medical, Inc. · Jan 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942 · Medtronic Sofamor Danek · Dec 2007
ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
K072081 · Alphatec Spine, Inc. · Oct 2007
MODIFICATION TO OASYS SYSTEM
K072568 · Stryker Spine · Oct 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K070742 · Medtronic Sofamor Danek · Sep 2007
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
K070300 · Depuy Spine, Inc. · Apr 2007