Cleared Traditional

K201521 - Medina Anterior Cervical Plate System

K201521 is the FDA 510(k) clearance for Medina Anterior Cervical Plate System by Alliance Partners, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K201521 · Alliance Partners, LLC · Orthopedic device
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Aug 2020
Decision
59d
Days
Class 2
Risk

K201521 is an FDA 510(k) clearance for the Medina Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Alliance Partners, LLC (San Antonio, US). The FDA issued a Cleared decision on August 6, 2020 after a review of 59 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 Alliance Partners, LLC devices

Submission Details

510(k) Number K201521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2020
Decision Date August 06, 2020
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Empirical Testing Corp
Nathan Wright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 373
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K201521.
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Admiral ACP System
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Cervical Plate System
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Aurora® Anterior Lumbar Plate Sytstem
K201079 · Prism Surgical Design Pty , Ltd. · Aug 2020
AccelFix Lumbar Plate System
K192481 · L & K Biomed Co., Ltd. · Jul 2020
Transept Cervical Plate System
K200927 · Neurostructures, Inc. · Jul 2020