Cleared Traditional

K123578 - ANTERIOR CERVICAL PLATE SYSTEM

K123578 is an FDA 510(k) clearance for ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Weigao Orthopaedic Device Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K123578 · Weigao Orthopaedic Device Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
73d
Days
Class 2
Risk

K123578 is an FDA 510(k) clearance for the ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Weigao Orthopaedic Device Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 1, 2013 after a review of 73 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 Weigao Orthopaedic Device Co., Ltd. devices

FDA 510(k) Submission Details - K123578

510(k) Number K123578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2012
Decision Date February 01, 2013
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 K123578.
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013
IRIS ANTERIOR CERVICAL PLATE
K130202 · Life Spine, Inc. · Apr 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · Nuvasive, Inc. · Feb 2013
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · Medos International SARL · Dec 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · Corelink, LLC · Dec 2012
V2F ANTERIOR FIXATION SYSTEM
K122733 · Zimmer Spine, Inc. · Dec 2012