Cleared Traditional

K023319 - NUVASIVE MASH

K023319 is an FDA 510(k) clearance for NUVASIVE MASH, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K023319 · Nuvasive, Inc. · Orthopedic device
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Mar 2003
Decision
151d
Days
Class 2
Risk

K023319 is an FDA 510(k) clearance for the NUVASIVE MASH. 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 March 4, 2003 after a review of 151 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K023319

510(k) Number K023319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2002
Decision Date March 04, 2003
Days to Decision 151 days
Submission Type Traditional
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 slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 K023319.
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · Medtronic Sofamor Danek · Apr 2003
VERTE-STACK SPINAL SYSTEM
K030601 · Medtronic Sofamor Danek · Mar 2003
SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW)
K024364 · Synthes (Usa) · Mar 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · Medtronic Sofamor Danek, Inc. · Feb 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · Depuyacromed · Feb 2003
DEVEX MESH SYSTEM
K023835 · Depuyacromed · Jan 2003