Cleared Traditional

Prase-AP Anterior Cervical Plate System (K202878) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 243
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