Cleared Special

HEDRON? Cervical Spacers (HEDRON C-MIS? Spacer)

K253876 · Globus Medical, Inc. · Orthopedic

Dec 2025

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K253876 is an FDA 510(k) clearance for the HEDRON? Cervical Spacers (HEDRON C-MIS? Spacer), a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 22, 2025, 18 days after receiving the submission on December 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K253876 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2025
Decision Date	December 22, 2025
Days to Decision	18 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.