Cleared Traditional

IntraOp Alignment System

K240199 · Alphatec Spine, Inc. · Radiology

May 2024

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K240199 is an FDA 510(k) clearance for the IntraOp Alignment System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 22, 2024, 118 days after receiving the submission on January 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K240199 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2024
Decision Date	May 22, 2024
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy