Cleared Special

K133567 - UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

K133567 is an FDA 510(k) clearance for UNIFY DYNAMIC ANTERIOR CERVICAL PLATE S..., manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 92-day FDA review.

K133567 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
92d
Days
Class 2
Risk

K133567 is an FDA 510(k) clearance for the UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on February 20, 2014 after a review of 92 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133567

510(k) Number K133567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2013
Decision Date February 20, 2014
Days to Decision 92 days
Submission Type Special
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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

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 667
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K133567.
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
NEOPLATE SPINE ANTERIOR FIXATION SYSTEM
K132653 · Neoortho Productos Orthopedicos S/A · May 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · Reliance Medical Systems, LLC · Apr 2014
VELOX ANTERIOR CERVICAL PLATE SYSTEM
K131521 · Spinecraft, LLC · Dec 2013
ASCOT
K132310 · Backroads Consulting, Inc. · Dec 2013
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · Nexxt Spine, LLC · Dec 2013
K133567 · UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary Globus Medical, Inc.