Cleared Special

K122910 - ARCHON ANTERIOR CERVICAL PLATE SYSTE,

K122910 is an FDA 510(k) clearance for ARCHON ANTERIOR CERVICAL PLATE SYSTE, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 20-day FDA review.

K122910 · Nu Vasive, Incorporated · Orthopedic device
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Oct 2012
Decision
20d
Days
Class 2
Risk

K122910 is an FDA 510(k) clearance for the ARCHON ANTERIOR CERVICAL PLATE SYSTE,. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on October 11, 2012 after a review of 20 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K122910

510(k) Number K122910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date October 11, 2012
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 611
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K122910.
REX ANTERIOR CERVICAL PLATE SYSTEM
K121862 · Dio Medical Co., Ltd. · Oct 2012
NUVASIVE SAGE LATERAL PLATE SYSTEM
K121815 · Nuvasive, Inc. · Oct 2012
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
K122497 · Medical Design, LLC · Oct 2012
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
K121078 · Accel Spine · Sep 2012
QUINTEX CERVICAL PLATING SYSTEM
K121801 · Aesculap Implant Systems, LLC · Sep 2012
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM
K122216 · Reliance Medical Systems, LLC · Sep 2012