Cleared Traditional

K063100 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE

K063100 is an FDA 510(k) clearance for ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K063100

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.

KWQ Device Classification - Class 2, Special Controls

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 598
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