Cleared Traditional

K131521 - VELOX ANTERIOR CERVICAL PLATE SYSTEM

K131521 is an FDA 510(k) clearance for VELOX ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Spinecraft, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K131521 · Spinecraft, LLC · Orthopedic device
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Dec 2013
Decision
210d
Days
Class 2
Risk

K131521 is an FDA 510(k) clearance for the VELOX ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinecraft, LLC (Westmont, US). The FDA issued a Cleared decision on December 24, 2013 after a review of 210 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 Spinecraft, LLC devices

FDA 510(k) Submission Details - K131521

510(k) Number K131521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date December 24, 2013
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
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 471
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131521.
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · Reliance Medical Systems, LLC · Apr 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
CAYMAN MI PLATE SYSTEM
K131533 · K2m, Inc. · Nov 2013