Cleared Traditional

Cervical Interbody and VBR Fusion System

K252219 · Sync Surgical · Orthopedic

Jan 2026

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K252219 is an FDA 510(k) clearance for the Cervical Interbody and VBR Fusion System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Sync Surgical (Plano, US). The FDA issued a Cleared decision on January 14, 2026, 183 days after receiving the submission on July 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K252219 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2025
Decision Date	January 14, 2026
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	ODP — Intervertebral Fusion Device With Bone Graft, 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.