Cleared Traditional

K140280 - FORTICORE

K140280 is an FDA 510(k) clearance for FORTICORE, manufactured by Nanovis, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K140280 · Nanovis, LLC · Orthopedic device
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Sep 2014
Decision
213d
Days
Class 2
Risk

K140280 is an FDA 510(k) clearance for the FORTICORE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Nanovis, LLC (Chesterland, US). The FDA issued a Cleared decision on September 5, 2014 after a review of 213 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 Nanovis, LLC devices

FDA 510(k) Submission Details - K140280

510(k) Number K140280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2014
Decision Date September 05, 2014
Days to Decision 213 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 122d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 252
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K140280.
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K142026 · Spinefrontier, Inc. · Oct 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · Medtronic Sofamor Danek USA, Inc. · Oct 2014
ARENA-C
K141337 · Spinefrontier, Inc. · Sep 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · Nu Vasive, Incorporated · Jul 2014
MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
K132732 · Medyssey USA, Inc. · Jul 2014