Cleared Traditional

HILINE? Fixation System

K230565 · Globus Medical, Inc. · Orthopedic

Apr 2023

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K230565 is an FDA 510(k) clearance for the HILINE? Fixation System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 20, 2023, 50 days after receiving the submission on March 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K230565 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2023
Decision Date	April 20, 2023
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.