Cleared Special

INERTIA? CONNEXX? Modular Pedicle Screw System

K231799 · Nexxt Spine, LLC · Orthopedic

Jul 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K231799 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 20, 2023, 30 days after receiving the submission on June 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K231799 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2023
Decision Date	July 20, 2023
Days to Decision	30 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.