Cleared Special

K160874 - Nanovis Intervertebral Body Fusion System and FortiCore®

K160874 is an FDA 510(k) clearance for Nanovis Intervertebral Body Fusion Syst..., manufactured by Nanovis, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 90-day FDA review.

K160874 · Nanovis, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
90d
Days
Class 2
Risk

K160874 is an FDA 510(k) clearance for the Nanovis Intervertebral Body Fusion System and FortiCore®. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Nanovis, LLC (Columbia City, US). The FDA issued a Cleared decision on June 28, 2016 after a review of 90 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. 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 - K160874

510(k) Number K160874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date June 28, 2016
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 Consultant

Backroads Consulting, Inc.
Karen E. Warden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 896
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K160874.
PROW FUSION-V
K153786 · Nlt Spine, Ltd. · Jul 2016
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K160715 · Stryker Corporation · Jul 2016
Spinal Jaxx Interbody Fusion Device
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CoRoent® Ti-C System
K160916 · Nu Vasive, Incorporated · Jun 2016
Lucent Intervertebral Body Fusion Device
K152011 · Spinal Elements, Inc. · Jun 2016
LATERAL Spine Truss System
K153436 · 4Web, Inc. · Jun 2016