Cleared Special

INERTIA CONNEXX Modular Pedicle Screw System

K221905 · Nexxt Spine, LLC · Orthopedic

Jul 2022

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K221905 is an FDA 510(k) clearance for the INERTIA CONNEXX Modular Pedicle Screw 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 July 28, 2022, 28 days after receiving the submission on June 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K221905 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2022
Decision Date	July 28, 2022
Days to Decision	28 days
Submission Type	Special
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.