Cleared Traditional

K113509 - LEXUS ANTERIOR CERVICAL PLATE SYSTEM

K113509 is an FDA 510(k) clearance for LEXUS ANTERIOR CERVICAL PLATE SYSTEM, manufactured by L & K Biomed Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K113509 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 2012
Decision
53d
Days
Class 2
Risk

K113509 is an FDA 510(k) clearance for the LEXUS ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Geumcheon-Gu, Seoul, KR). The FDA issued a Cleared decision on January 20, 2012 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all L & K Biomed Co., Ltd. devices

FDA 510(k) Submission Details - K113509

510(k) Number K113509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2011
Decision Date January 20, 2012
Days to Decision 53 days
Submission Type Traditional
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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K113509.
CERVICAL PLATE
K113170 · Eisertech, LLC · Apr 2012
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM
K112861 · Sintea Plustek, LLC · Feb 2012
CARDIFF ANTERIOR CERVICAL PLATE SYSTEM
K112206 · Seaspine, Inc. · Jan 2012
K2M, PYRENEES CERVICAL PLATE SYSTEM
K113329 · K2m, Inc. · Jan 2012
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · Genesys Spine · Dec 2011
ZAVATION CERVICAL PLATE SYSTEM
K112533 · Zavation, LLC · Dec 2011