Cleared Traditional

K131200 - ASPIRON ACP SYSTEM

K131200 is the FDA 510(k) clearance for ASPIRON ACP SYSTEM by U&I Corporation. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K131200 · U&I Corporation · Orthopedic device
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Aug 2013
Decision
122d
Days
Class 2
Risk

K131200 is an FDA 510(k) clearance for the ASPIRON ACP SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on August 29, 2013 after a review of 122 days - within the typical 510(k) review window.

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 U&I Corporation devices

Submission Details

510(k) Number K131200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2013
Decision Date August 29, 2013
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 436
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K131200.
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AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013