Cleared Traditional

K121514 - ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

K121514 is an FDA 510(k) clearance for ANODYNE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Corelink, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K121514 · Corelink, LLC · Orthopedic device
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Dec 2012
Decision
206d
Days
Class 2
Risk

K121514 is an FDA 510(k) clearance for the ANODYNE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Corelink, LLC (Washington, US). The FDA issued a Cleared decision on December 14, 2012 after a review of 206 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 Corelink, LLC devices

FDA 510(k) Submission Details - K121514

510(k) Number K121514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2012
Decision Date December 14, 2012
Days to Decision 206 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
84d slower than avg
Panel avg: 122d · This submission: 206d
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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K121514.
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · Nuvasive, Inc. · Feb 2013
ANTERIOR CERVICAL PLATE SYSTEM
K123578 · Weigao Orthopaedic Device Co., Ltd. · Feb 2013
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · Medos International SARL · Dec 2012
V2F ANTERIOR FIXATION SYSTEM
K122733 · Zimmer Spine, Inc. · Dec 2012
ZOU ANTERIOR LUMBAR PLATE SYSTEM
K121791 · Corelink, LLC · Nov 2012
REX ANTERIOR CERVICAL PLATE SYSTEM
K121862 · Dio Medical Co., Ltd. · Oct 2012