Cleared Traditional

K134011 - GENERAL SPINAL SYSTEM

K134011 is an FDA 510(k) clearance for GENERAL SPINAL SYSTEM, manufactured by Changzhou Dean Medical Instrument Co, Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K134011 · Changzhou Dean Medical Instrument Co, Ltd. · Orthopedic device
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Sep 2014
Decision
247d
Days
Class 2
Risk

K134011 is an FDA 510(k) clearance for the GENERAL SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Changzhou Dean Medical Instrument Co, Ltd. (Shanghai, CN). The FDA issued a Cleared decision on September 3, 2014 after a review of 247 days - an extended review cycle.

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 Changzhou Dean Medical Instrument Co, Ltd. devices

FDA 510(k) Submission Details - K134011

510(k) Number K134011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date September 03, 2014
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 181
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K134011.
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ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
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