Cleared Traditional

K101446 - EMERALD SPINAL SYSTEM

K101446 is an FDA 510(k) clearance for EMERALD SPINAL SYSTEM, manufactured by Mazor Surgical Technologies , Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K101446 · Mazor Surgical Technologies , Ltd. · Orthopedic device
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Jan 2011
Decision
241d
Days
Class 2
Risk

K101446 is an FDA 510(k) clearance for the EMERALD SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Mazor Surgical Technologies , Ltd. (Washington, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 241 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 Mazor Surgical Technologies , Ltd. devices

FDA 510(k) Submission Details - K101446

510(k) Number K101446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2010
Decision Date January 20, 2011
Days to Decision 241 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
119d slower than avg
Panel avg: 122d · This submission: 241d
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 199
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K101446.
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · Exactech, Inc. · Jan 2011
INERTIA PEDICLE SCREW SYSTEM
K101278 · Nexxt Spine, LLC · Dec 2010
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771 · Pioneer Surgical Technology · Aug 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · Spineart · Jul 2010