Cleared Traditional

ATEC Lateral Navigation Instruments

K223765 · Alphatec Spine, Inc. · Orthopedic

Mar 2023

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K223765 is an FDA 510(k) clearance for the ATEC Lateral 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 March 23, 2023, 98 days after receiving the submission on December 15, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K223765 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2022
Decision Date	March 23, 2023
Days to Decision	98 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.