Cleared Special

K140742 - RELIANCE ANTERIOR CERVICAL PLATE

K140742 is the FDA 510(k) clearance for RELIANCE ANTERIOR CERVICAL PLATE by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 31-day FDA review.

K140742 · Reliance Medical Systems, LLC · Orthopedic device
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Apr 2014
Decision
31d
Days
Class 2
Risk

K140742 is an FDA 510(k) clearance for the RELIANCE ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on April 25, 2014 after a review of 31 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K140742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2014
Decision Date April 25, 2014
Days to Decision 31 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 436
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K140742.
SKYHAWK LATERAL PLATE SYSTEM
K140260 · Orthofix, Inc. · Jul 2014
META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K133567 · Globus Medical, Inc. · Feb 2014
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · Corelink, LLC · Dec 2013
ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025 · Nuvasive, Inc. · Nov 2013