Cleared Traditional

K130640 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K130640 is the FDA 510(k) clearance for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K130640 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2013
Decision
85d
Days
Class 2
Risk

K130640 is an FDA 510(k) clearance for the ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 4, 2013 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K130640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date June 04, 2013
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K130640.
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
K132324 · Medos International SARL · Sep 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · Nuvasive, Inc. · Aug 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013
IRIS ANTERIOR CERVICAL PLATE
K130202 · Life Spine, Inc. · Apr 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · Nuvasive, Inc. · Feb 2013