Cleared Traditional

Invictus Robotic Navigation Instruments

K232044 · Alphatec Spine, Inc. · Orthopedic

Oct 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K232044 is an FDA 510(k) clearance for the Invictus Robotic Navigation Instruments, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 6, 2023, 88 days after receiving the submission on July 10, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K232044 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2023
Decision Date	October 06, 2023
Days to Decision	88 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.