Cleared Special

K061274 - VENTURE ANTERIOR CERVICAL PLATE SYSTEM

K061274 is the FDA 510(k) clearance for VENTURE ANTERIOR CERVICAL PLATE SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 17-day FDA review.

K061274 · Medtronic Sofamor Danek · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2006
Decision
17d
Days
Class 2
Risk

K061274 is an FDA 510(k) clearance for the VENTURE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 devices

Submission Details

510(k) Number K061274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2006
Decision Date May 25, 2006
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K061274.
LATERAL PLATE SYSTEM
K061789 · Nuvasive, Inc. · Aug 2006
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · Blackstone Medical, Inc. · Jul 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · Innovasis, Inc. · Jun 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · Ebi, L.P. · Mar 2006
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
K053581 · Nuvasive, Inc. · Feb 2006
AEGIS ANTERIOR LUMBAR PLATE SYSTEM
K052546 · Depuy Spine, Inc. · Feb 2006