Cleared Special

K132366 - SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

K132366 is an FDA 510(k) clearance for SPINAL INTERVERTEBRAL BODY FIXATION ORT..., manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 35-day FDA review.

K132366 · Accel Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
35d
Days
Class 2
Risk

K132366 is an FDA 510(k) clearance for the SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on September 3, 2013 after a review of 35 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.

FDA 510(k) Submission Details - K132366

510(k) Number K132366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2013
Decision Date September 03, 2013
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 660
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K132366.
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TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM
K132012 · Zimmer Spine, Inc. · Aug 2013