Cleared Traditional

K140479 - COROENT XL-F SYSTEM

K140479 is an FDA 510(k) clearance for COROENT XL-F SYSTEM, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K140479 · Nu Vasive, Incorporated · Orthopedic device
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Jul 2014
Decision
152d
Days
Class 2
Risk

K140479 is an FDA 510(k) clearance for the COROENT XL-F SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on July 28, 2014 after a review of 152 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K140479

510(k) Number K140479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2014
Decision Date July 28, 2014
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 198
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K140479.
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K142095 · Renovis Surgical Technologies, Inc. · Oct 2014
BIOMET FUSION SYSTEM
K141791 · Biomet Spine · Oct 2014
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
K133947 · X-Spine Systems, Inc. · Jul 2014
CHESAPEAKE SPINAL SYSTEM
K133494 · K2m, Inc. · Jun 2014
AERO-AL LUMBAR CAGE SYSTEM
K133328 · Stryker Corporation · May 2014
PROPOSED OPTIMUS
K132596 · Custom Spine, Inc. · Apr 2014