Cleared Traditional

Invictus? Bone Cement, Invictus Spinal Fixation System

K221926 · Alphatec Spine, Inc. · Orthopedic

Dec 2022

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K221926 is an FDA 510(k) clearance for the Invictus? Bone Cement, Invictus Spinal Fixation System, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 20, 2022, 172 days after receiving the submission on July 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K221926 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2022
Decision Date	December 20, 2022
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.