Cleared Traditional

Inertia Pedicle Screw and Deformity Correxxion System

K153453 · Nexxt Spine, LLC · Orthopedic

Apr 2016

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K153453 is an FDA 510(k) clearance for the Inertia Pedicle Screw and Deformity Correxxion System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on April 26, 2016, 148 days after receiving the submission on November 30, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K153453 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2015
Decision Date	April 26, 2016
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.