Cleared Traditional

K082617 - TRAUSON GENERAL SPINAL SYSTEM (GSS)

K082617 is an FDA 510(k) clearance for TRAUSON GENERAL SPINAL SYSTEM (GSS), manufactured by Trauson (Jiangsu) Medical Instrument Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K082617 · Trauson (Jiangsu) Medical Instrument Co., Ltd. · Orthopedic device
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Jan 2009
Decision
128d
Days
Class 2
Risk

K082617 is an FDA 510(k) clearance for the TRAUSON GENERAL SPINAL SYSTEM (GSS). Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Trauson (Jiangsu) Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 15, 2009 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Trauson (Jiangsu) Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K082617

510(k) Number K082617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2008
Decision Date January 15, 2009
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 201
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K082617.
RELIANCE SPINAL SCREW SYSTEM
K081978 · Reliance Medical Systems, LLC · Mar 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · Theken Spine, LLC · Mar 2009
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145 · Solco Biomedical Co., Ltd. · Nov 2008