Cleared Traditional

K140234 - ASPIRON ACP SYSTEM

K140234 is an FDA 510(k) clearance for ASPIRON ACP SYSTEM, manufactured by U&I Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K140234 · U&I Corp. · Orthopedic device
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Jun 2014
Decision
124d
Days
Class 2
Risk

K140234 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 Corp. (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on June 2, 2014 after a review of 124 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 Corp. devices

FDA 510(k) Submission Details - K140234

510(k) Number K140234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2014
Decision Date June 02, 2014
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 K140234.
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
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META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K140611 · Zimmer Spine, Inc. · May 2014
RELIANCE ANTERIOR CERVICAL PLATE
K140742 · Reliance Medical Systems, LLC · Apr 2014
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K133567 · Globus Medical, Inc. · Feb 2014