Cleared Traditional

K110990 - GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM

K110990 is an FDA 510(k) clearance for GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Gold Standard Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K110990 · Gold Standard Orthopedics, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2011
Decision
108d
Days
Class 2
Risk

K110990 is an FDA 510(k) clearance for the GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Gold Standard Orthopedics, LLC (Warsaw, US). The FDA issued a Cleared decision on July 25, 2011 after a review of 108 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 Gold Standard Orthopedics, LLC devices

FDA 510(k) Submission Details - K110990

510(k) Number K110990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2011
Decision Date July 25, 2011
Days to Decision 108 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 122d · This submission: 108d
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 505
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K110990.
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM
K111796 · Zimmer Spine, Inc. · Oct 2011
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K111528 · Pioneer Surgical Technology, Inc. · Aug 2011
PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES)
K111135 · K2m, Inc. · Aug 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · Nuvasive, Inc. · Jul 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · Nuvasive, Inc. · Jun 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · Life Spine · Jun 2011