Cleared Traditional

K143688 - ASFORA ANTERIOR CERVICAL PLATE SYSTEM

K143688 is the FDA 510(k) clearance for ASFORA ANTERIOR CERVICAL PLATE SYSTEM by Medical Designs, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K143688 · Medical Designs, LLC · Orthopedic device
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Jul 2015
Decision
189d
Days
Class 2
Risk

K143688 is an FDA 510(k) clearance for the ASFORA ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medical Designs, LLC (Sioux Falls, US). The FDA issued a Cleared decision on July 1, 2015 after a review of 189 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 Medical Designs, LLC devices

Submission Details

510(k) Number K143688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date July 01, 2015
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 424
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K143688.
Pyrenees Cervical Plate System
K152015 · K2m, Inc. · Sep 2015
ACP 1 Anterior Cervical Plating System
K150700 · Stryker Corporation · Jul 2015
CastleLoc-P Anterior Cervical Plate System
K143271 · L & K Biomed Co., Ltd. · Jul 2015
Azure Anterior Cervical Plate System
K143028 · Orthofix, Inc. · May 2015
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015
LnK Anterior Cervical Plate System
K143279 · L & K Biomed Co., Ltd. · Mar 2015