Cleared Traditional

K132310 - ASCOT

K132310 is an FDA 510(k) clearance for ASCOT, manufactured by Backroads Consulting, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K132310 · Backroads Consulting, Inc. · Orthopedic device
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Dec 2013
Decision
151d
Days
Class 2
Risk

K132310 is an FDA 510(k) clearance for the ASCOT. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Backroads Consulting, Inc. (Chesterland, US). The FDA issued a Cleared decision on December 23, 2013 after a review of 151 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 Backroads Consulting, Inc. devices

FDA 510(k) Submission Details - K132310

510(k) Number K132310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2013
Decision Date December 23, 2013
Days to Decision 151 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
29d slower than avg
Panel avg: 122d · This submission: 151d
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 491
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K132310.
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K133475 · Nexxt Spine, LLC · Dec 2013
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K132994 · Corelink, LLC · Dec 2013
ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025 · Nuvasive, Inc. · Nov 2013