Cleared Traditional

NEXXT SPINE NAVIGATION System

K220291 · Nexxt Spine, LLC · Orthopedic

Mar 2022

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K220291 is an FDA 510(k) clearance for the NEXXT SPINE NAVIGATION System, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on March 31, 2022, 58 days after receiving the submission on February 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K220291 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2022
Decision Date	March 31, 2022
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OLO — Orthopedic Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.