Cleared Traditional

SABER-C System

K250540 · Elevation Spine · Orthopedic

Aug 2025

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K250540 is an FDA 510(k) clearance for the SABER-C System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Elevation Spine (Monteray, US). The FDA issued a Cleared decision on August 8, 2025, 165 days after receiving the submission on February 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250540 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2025
Decision Date	August 08, 2025
Days to Decision	165 days
Submission Type	Traditional
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.