Cleared Traditional

K152623 - ATLANTIS Anterior Cervical Plate System

K152623 is an FDA 510(k) clearance for ATLANTIS Anterior Cervical Plate System, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K152623 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Nov 2015
Decision
59d
Days
Class 2
Risk

K152623 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 November 12, 2015 after a review of 59 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

FDA 510(k) Submission Details - K152623

510(k) Number K152623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2015
Decision Date November 12, 2015
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 K152623.
Anterior Cervical Plate System
K151553 · Osteomed Implantes, Ltda · Feb 2016
Zero-P Natural Plate System
K152239 · Synthes (Usa), LLC · Dec 2015
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
Amendia Cervical Plate System
K152455 · Amendia, Inc. · Oct 2015
Renovis Anterior Cervical Plate System
K152193 · Renovis Surgical Technologies, Inc. · Sep 2015
Pyrenees Cervical Plate System
K152281 · K2m · Sep 2015