Cleared Traditional

K121791 - ZOU ANTERIOR LUMBAR PLATE SYSTEM

K121791 is an FDA 510(k) clearance for ZOU ANTERIOR LUMBAR 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 153-day FDA review.

K121791 · Corelink, LLC · Orthopedic device
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Nov 2012
Decision
153d
Days
Class 2
Risk

K121791 is an FDA 510(k) clearance for the ZOU ANTERIOR LUMBAR 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 November 19, 2012 after a review of 153 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 - K121791

510(k) Number K121791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2012
Decision Date November 19, 2012
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 K121791.
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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
REX ANTERIOR CERVICAL PLATE SYSTEM
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K121815 · Nuvasive, Inc. · Oct 2012
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM
K122497 · Medical Design, LLC · Oct 2012