Cleared Traditional

K063100 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K063100 is the FDA 510(k) clearance for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K063100 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2007
Decision
136d
Days
Class 2
Risk

K063100 is an FDA 510(k) clearance for the ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek, Inc. devices

Submission Details

510(k) Number K063100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2006
Decision Date February 23, 2007
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 K063100.
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
K070273 · Nuvasive, Inc. · Apr 2007
ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K063430 · Stryker Spine · Mar 2007
LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEM
K070285 · Life Spine · Mar 2007
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
K063544 · K2m, Inc. · Feb 2007
NUVASIVE ACP4 SYSTEM
K062590 · Nuvasive, Inc. · Jan 2007
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · Globus Medical, Inc. · Dec 2006