Cleared Special

K162250 - FortiBridge Anterior Cervical Plate System

K162250 is an FDA 510(k) clearance for FortiBridge Anterior Cervical Plate System, manufactured by Nanovis Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 77-day FDA review.

K162250 · Nanovis Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
77d
Days
Class 2
Risk

K162250 is an FDA 510(k) clearance for the FortiBridge Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nanovis Spine, LLC (Columbia City, US). The FDA issued a Cleared decision on October 26, 2016 after a review of 77 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K162250

510(k) Number K162250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2016
Decision Date October 26, 2016
Days to Decision 77 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 661
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K162250.
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System
K162194 · Medicrea International SA · Dec 2016
AccuFit Lateral Plate System
K162211 · Precision Spine, Inc. · Nov 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
Tangis Anterior Cervical Plate
K161524 · Nvision Biomedical Technologies, LLC · Sep 2016
ZION Anterior Cervical Fixation System
K160702 · Astura Medical · Aug 2016
K162250 · FortiBridge Anterior Cervical Plate System
Download PDF FDA Summary Nanovis Spine, LLC