Cleared Special

TriALTIS? Spine System

K233684 · Medos International SARL · Orthopedic

Dec 2023

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K233684 is an FDA 510(k) clearance for the TriALTIS? Spine System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on December 12, 2023, 26 days after receiving the submission on November 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K233684 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2023
Decision Date	December 12, 2023
Days to Decision	26 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.