Cleared Special

K052210 - NUVASIVE COROENT EXTENSURE SYSTEM

K052210 is an FDA 510(k) clearance for NUVASIVE COROENT EXTENSURE SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 119-day FDA review.

K052210 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
119d
Days
Class 2
Risk

K052210 is an FDA 510(k) clearance for the NUVASIVE COROENT EXTENSURE SYSTEM. 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 December 12, 2005 after a review of 119 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.

FDA 510(k) Submission Details - K052210

510(k) Number K052210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2005
Decision Date December 12, 2005
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052210.
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS
K053292 · Scient'X USA, Inc. · Jan 2006
SEASPINE VBR SYSTEM
K052170 · Seaspine, Inc. · Dec 2005
GRAFTCAGE TLX
K051781 · Osteotech, Inc. · Dec 2005
GRAFTCAGE ACX
K053080 · Osteotech, Inc. · Dec 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM
K052950 · Zimmer Trabecular · Nov 2005
K052210 · NUVASIVE COROENT EXTENSURE SYSTEM
Download PDF FDA Summary Nuvasive, Inc.