Cleared Special

K032476 - NUVASIVE MESH

K032476 is the FDA 510(k) clearance for NUVASIVE MESH by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 93-day FDA review.

K032476 · Nuvasive, Inc. · Orthopedic device
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Nov 2003
Decision
93d
Days
Class 2
Risk

K032476 is an FDA 510(k) clearance for the NUVASIVE MESH. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on November 13, 2003 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Standard predicate reliance. 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 K032476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2003
Decision Date November 13, 2003
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 161
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K032476.
VERTE-STACK SPINAL SYSTEM
K040167 · Medtronic Sofamor Danek · Feb 2004
TITANIUM MESH SYSTEM
K032371 · Encore Medical, L.P. · Feb 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · Implex Corp. · Oct 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · Blackstone Medical, Inc. · Oct 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · Spinal Concepts, Inc. · Aug 2003