Cleared Special

K112920 - RANGE SPINAL SYSTEM (MESA AND DENALI)

K112920 is the FDA 510(k) clearance for RANGE SPINAL SYSTEM (MESA AND DENALI) by K2m, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 79-day FDA review.

K112920 · K2m, Inc. · Orthopedic device
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Dec 2011
Decision
79d
Days
Class 2
Risk

K112920 is an FDA 510(k) clearance for the RANGE SPINAL SYSTEM (MESA AND DENALI). Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 79 days - a notably fast clearance cycle.

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. 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 K2m, Inc. devices

Submission Details

510(k) Number K112920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 21, 2011
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K112920.
TIGER SPINE SYSTEM
K120696 · Corelink, LLC · Apr 2012
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · Life Spine · Mar 2012
SYNTHES USS CONNECTORS
K113149 · Synthes Spine · Feb 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011
CAPSURE(R) PS SYSTEM
K111913 · Spine Wave, Inc. · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K112108 · Spineart · Aug 2011