Cleared Traditional

K151458 - Double Medical Universal Spine System

K151458 is an FDA 510(k) clearance for Double Medical Universal Spine System, manufactured by Double Medical Technology, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K151458 · Double Medical Technology, Inc. · Orthopedic device
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Aug 2016
Decision
448d
Days
Class 2
Risk

K151458 is an FDA 510(k) clearance for the Double Medical Universal Spine System. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on August 22, 2016 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Double Medical Technology, Inc. devices

FDA 510(k) Submission Details - K151458

510(k) Number K151458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date August 22, 2016
Days to Decision 448 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
326d slower than avg
Panel avg: 122d · This submission: 448d
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 192
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K151458.
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Reliance Spinal Screw System
K152131 · Reliance Medical Systems, LLC · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015