Cleared Traditional

Invictus? Spinal Fixation System

K232275 · Alphatec Spine, Inc. · Orthopedic

Sep 2023

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K232275 is an FDA 510(k) clearance for the Invictus? 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 September 27, 2023, 58 days after receiving the submission on July 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K232275 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2023
Decision Date	September 27, 2023
Days to Decision	58 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.