Cleared Traditional

K202878 - Prase-AP Anterior Cervical Plate System

K202878 is an FDA 510(k) clearance for Prase-AP Anterior Cervical Plate System, manufactured by Gbs Commonwealth Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K202878 · Gbs Commonwealth Co., Ltd. · Orthopedic device
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Jan 2021
Decision
123d
Days
Class 2
Risk

K202878 is an FDA 510(k) clearance for the Prase-AP Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Gbs Commonwealth Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on January 29, 2021 after a review of 123 days - within the typical 510(k) review window.

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 Gbs Commonwealth Co., Ltd. devices

FDA 510(k) Submission Details - K202878

510(k) Number K202878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date January 29, 2021
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K202878.
APOLLO Anterior Cervical Plate (ACP) System
K210325 · Aurora Spine, Inc. · Mar 2021
Cure 2.0 Anterior Cervical Plate (ACP) System
K210286 · Meditech Spine, LLC · Mar 2021
Lumbar Spine Truss System Plating Solution (LSTS-PS)
K203065 · 4Web, Inc. · Mar 2021
NuVasive ACP System
K203253 · Nu Vasive, Incorporated · Dec 2020
Anterior Cervical Plate System
K202972 · Nutech Spine and Biologics · Nov 2020
KASILOF Cervical Plate System
K203154 · Kahtnu Surgical, Inc. · Nov 2020