Cleared Traditional

K190565 - Cervical Plate

K190565 is the FDA 510(k) clearance for Cervical Plate by Eisertech, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K190565 · Eisertech, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2019
Decision
87d
Days
Class 2
Risk

K190565 is an FDA 510(k) clearance for the Cervical Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Eisertech, LLC (San Diego, US). The FDA issued a Cleared decision on May 31, 2019 after a review of 87 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 Eisertech, LLC devices

Submission Details

510(k) Number K190565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date May 31, 2019
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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

Mrc-X, LLC
Dawn Norman

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 K190565.
Cyclops™ Anterior Cervical Plate System
K191786 · Degen Medical, Inc. · Aug 2019
Binary® Anterior Cervical Plate System
K192076 · Genesys Spine · Aug 2019
Lateral Plate System
K190016 · Corelink, LLC · Jun 2019
Fuji Cervical Plate System
K183084 · Altus Partners, LLC · May 2019
CAYMAN LP Plate System
K190584 · K2m, Inc. · May 2019
MVP Cervical Plate System
K190170 · GS Medical Co., Ltd. · May 2019