Cleared Traditional

K132994 - ANODYNE ANTERIOR CERVICAL PLATE SYSTEM

K132994 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 72-day FDA review.

K132994 · Corelink, LLC · Orthopedic device
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Dec 2013
Decision
72d
Days
Class 2
Risk

K132994 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 (Round Rock, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 72 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 Corelink, LLC devices

FDA 510(k) Submission Details - K132994

510(k) Number K132994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2013
Decision Date December 05, 2013
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K132994.
VELOX ANTERIOR CERVICAL PLATE SYSTEM
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ASCOT
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ARCHON ANTERIOR CERVICAL PLATE SYSTEM
K131025 · Nuvasive, Inc. · Nov 2013
CAYMAN MI PLATE SYSTEM
K131533 · K2m, Inc. · Nov 2013
ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
K132589 · Life Spine, Inc. · Oct 2013