Cleared Traditional

Invictus? Small Stature Spinal Fixation System

K241519 · Alphatec Spine, Inc. · Orthopedic

Jun 2024

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K241519 is an FDA 510(k) clearance for the Invictus? Small Stature Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 21, 2024, 23 days after receiving the submission on May 29, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K241519 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2024
Decision Date	June 21, 2024
Days to Decision	23 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.