Cleared Traditional

ExcelsiusFlex?

K240721 · Globus Medical, Inc. · Orthopedic

Jun 2024

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K240721 is an FDA 510(k) clearance for the ExcelsiusFlex?, a Orthopedic Stereotaxic Instrument (Class II — Special Controls, product code OLO), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 14, 2024, 88 days after receiving the submission on March 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K240721 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2024
Decision Date	June 14, 2024
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.