Cleared Special

K062317 - MODIFICATION TO NUVASIVE SPHERX II SYSTEM

K062317 is the FDA 510(k) clearance for MODIFICATION TO NUVASIVE SPHERX II SYSTEM by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 23-day FDA review.

K062317 · Nuvasive, Inc. · Orthopedic device
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Sep 2006
Decision
23d
Days
Class 2
Risk

K062317 is an FDA 510(k) clearance for the MODIFICATION TO NUVASIVE SPHERX II SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

Submission Details

510(k) Number K062317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2006
Decision Date September 01, 2006
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K062317.
MANTIS SPINAL SYSTEM
K061813 · Stryker Spine · Sep 2006
SFX SNAP-FIT CROSS CONNECTOR
K062196 · Depuy Spine, Inc. · Sep 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364 · Life Spine · Sep 2006
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
K061441 · Ebi, L.P. · Jul 2006
CD HORIZON SPINAL SYSTEM
K061915 · Medtronic Sofamor Danek · Jul 2006
NUVASIVE SPHERX II SYSTEM
K061778 · Nuvasive, Inc. · Jul 2006