Cleared Traditional

K160604 - Cure Anterior Cervical Plate (ACP) System

K160604 is an FDA 510(k) clearance for Cure Anterior Cervical Plate (ACP) System, manufactured by Meditech Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K160604 · Meditech Spine, LLC · Orthopedic device
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Jul 2016
Decision
121d
Days
Class 2
Risk

K160604 is an FDA 510(k) clearance for the Cure™ Anterior Cervical Plate (ACP) System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Meditech Spine, LLC (Atlanta, US). The FDA issued a Cleared decision on July 1, 2016 after a review of 121 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 Meditech Spine, LLC devices

FDA 510(k) Submission Details - K160604

510(k) Number K160604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2016
Decision Date July 01, 2016
Days to Decision 121 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 122d · This submission: 121d
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 482
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K160604.
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · Medicrea International SA · Dec 2016
AccuFit Lateral Plate System
K162211 · Precision Spine, Inc. · Nov 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015