Cleared Traditional

K140003 - COROENT SMALL INTERBODY SYSTEM

K140003 is the FDA 510(k) clearance for COROENT SMALL INTERBODY SYSTEM by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K140003 · Nuvasive, Inc. · Orthopedic device
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Apr 2014
Decision
91d
Days
Class 2
Risk

K140003 is an FDA 510(k) clearance for the COROENT SMALL INTERBODY SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 91 days - within the typical 510(k) review window.

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 Nuvasive, Inc. devices

Submission Details

510(k) Number K140003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2014
Decision Date April 03, 2014
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K140003.
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · Nu Vasive, Incorporated · Jul 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013