FortiBridge Anterior Cervical Plate System

FDA 510(k) K162250 · Nanovis Spine, LLC

Substantially Equivalent

510(k) numberK162250

Submission

Device name
FortiBridge Anterior Cervical Plate System
Applicant
Nanovis Spine, LLC
Columbia City, IN, US
Received
August 10, 2016
Decision date
October 26, 2016
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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K261112CastleLoc-P Anterior Cervical Plate SystemKWQ · Special L&K BIOMED Co., Ltd.05/06/2026SE
K260570corra™ cervical plating systemKWQ · Traditional Carlsmed, Inc.04/22/2026SE
K260697VyPlate™ Anterior Cervical Plate SystemKWQ · Special Vy Spine, LLC03/27/2026SE
K260015ANTERIS Thoracolumbar Plate SystemKWQ · Traditional SpineCraft03/04/2026SE
K251940PathLoc Lumbar Plate SystemKWQ · Traditional L&K BIOMED Co., Ltd.03/03/2026SE
K254182AsterKWQ · Traditional Osteonic Co., Ltd.02/26/2026SE
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special 4Web, Inc.02/12/2026SE
K252611aprevo® cervical plating systemKWQ · Traditional Carlsmed, Inc.12/22/2025SE

More from Carlsmed, Inc.

510(k)DeviceDecision
K193211Nano FortiFix® SystemNKB · Traditional 03/20/2020SE
K143706FortiBridge Anterior Cervical Plate SystemKWQ · Traditional 04/10/2015SE

Questions and answers

When was FortiBridge Anterior Cervical Plate System cleared by the FDA?

FortiBridge Anterior Cervical Plate System (K162250) received a 510(k) decision of Substantially Equivalent on October 26, 2016, 77 days after the submission was received.

What is the product code of K162250?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.