Cleared Traditional

K103070 - GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +

K103070 is an FDA 510(k) clearance for GPS TM, manufactured by G Surgical Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K103070 · G Surgical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
86d
Days
Class 2
Risk

K103070 is an FDA 510(k) clearance for the GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM +. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by G Surgical Co., Ltd. (Bangkok, TH). The FDA issued a Cleared decision on January 12, 2011 after a review of 86 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 G Surgical Co., Ltd. devices

FDA 510(k) Submission Details - K103070

510(k) Number K103070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date January 12, 2011
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 507
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103070.
NUVASIVE TRAVERSE PLATE SYSTEM
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POLARIS SPINAL SYSTEM
K103393 · Biomet Spine · Feb 2011
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · Spinal Elements, Inc. · Oct 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · Ldr Spine USA · Sep 2010