Cleared Traditional

K211205 - Prase-C Anterior Cervical Plate System

K211205 is an FDA 510(k) clearance for Prase-C 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 112-day FDA review.

K211205 · Gbs Commonwealth Co., Ltd. · Orthopedic device
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Aug 2021
Decision
112d
Days
Class 2
Risk

K211205 is an FDA 510(k) clearance for the Prase-C 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 August 12, 2021 after a review of 112 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 - K211205

510(k) Number K211205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2021
Decision Date August 12, 2021
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
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 K211205.
EMERGE™ Anterior Cervical Plate System
K212405 · Evolution Spine · Sep 2021
Admiral ACP System
K212139 · SeaSpine Orthopedics Corporation · Sep 2021
Shoreline Threaded TruProfile® Plate
K211903 · SeaSpine Orthopedics Corporation · Aug 2021
Fixxsure Anterior Lumbar Plate and Screw System
K211932 · Oak Tree Engineering, LLC · Jul 2021
CervAlign® Anterior Cervical Plate System
K211408 · Pioneer Surgical Technology, Inc. · Jun 2021
PANAMA™ Anterior Cervical Plate (ACP) System
K210182 · Flospine · Apr 2021