Cleared Special

K110284 - NOVEL III SPINAL FIXATION AND ADJUSTABL...

K110284 is an FDA 510(k) clearance for NOVEL III SPINAL FIXATION AND ADJUSTABL..., manufactured by Medyssey Co, Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 127-day FDA review.

K110284 · Medyssey Co, Ltd. · Orthopedic device
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Jun 2011
Decision
127d
Days
Class 2
Risk

K110284 is an FDA 510(k) clearance for the NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medyssey Co, Ltd. (Murray, US). The FDA issued a Cleared decision on June 8, 2011 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

View all Medyssey Co, Ltd. devices

FDA 510(k) Submission Details - K110284

510(k) Number K110284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2011
Decision Date June 08, 2011
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 187
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K110284.
MESA SPINAL SYSTEM (KEYSTONE RODS)
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EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc. · Jul 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011
MOUNTAINEER OCT SPINAL SYSTEM
K103100 · Depuy Spine, Inc. · Nov 2010
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · Life Spine · Nov 2010