Nano FortiFix® System

FDA 510(k) K193211 · Nanovis Spine, LLC

Substantially Equivalent

510(k) numberK193211

Submission

Device name
Nano FortiFix® System
Applicant
Nanovis Spine, LLC
Columbia City, IN, US
Received
November 21, 2019
Decision date
March 20, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional Alphatec Spine, Inc.07/14/2026SE
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODNKB · Special S.M.A.I.O07/01/2026SE
K253045“Socko” Vimax Spinal Fixation SystemNKB · Traditional Socko Medical Co., Ltd.06/17/2026SE
K251251ChanPin Pedicle Screw Spinal SystemNKB · Traditional Chanpin Medtak Co., Ltd.06/09/2026SE
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K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…NKB · Traditional Globus Medical, Inc.05/07/2026SE
K261130AccelFix Spinal Fixation SystemNKB · Special L&K BIOMED Co., Ltd.05/05/2026SE

More from L&K BIOMED Co., Ltd.

510(k)DeviceDecision
K162250FortiBridge Anterior Cervical Plate SystemKWQ · Special 10/26/2016SE
K143706FortiBridge Anterior Cervical Plate SystemKWQ · Traditional 04/10/2015SE

Questions and answers

When was Nano FortiFix® System cleared by the FDA?

Nano FortiFix® System (K193211) received a 510(k) decision of Substantially Equivalent on March 20, 2020, 120 days after the submission was received.

What is the product code of K193211?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.