Cleared Traditional

K131025 - ARCHON ANTERIOR CERVICAL PLATE SYSTEM

K131025 is an FDA 510(k) clearance for ARCHON ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K131025 · Nuvasive, Inc. · Orthopedic device
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Nov 2013
Decision
229d
Days
Class 2
Risk

K131025 is an FDA 510(k) clearance for the ARCHON ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on November 27, 2013 after a review of 229 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvasive, Inc. devices

FDA 510(k) Submission Details - K131025

510(k) Number K131025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date November 27, 2013
Days to Decision 229 days
Submission Type Traditional
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
107d slower than avg
Panel avg: 122d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131025.
ASCOT
K132310 · Backroads Consulting, Inc. · Dec 2013
STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
K133475 · Nexxt Spine, LLC · Dec 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · Corelink, LLC · Dec 2013
CAYMAN MI PLATE SYSTEM
K131533 · K2m, Inc. · Nov 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589 · Life Spine, Inc. · Oct 2013
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST
K132324 · Medos International SARL · Sep 2013