Cleared Traditional

Advantage-C? Ti3D Cervical Interbody Fusion Device

K252711 · Intelivation Technologies · Orthopedic

Jan 2026

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K252711 is an FDA 510(k) clearance for the Advantage-C? Ti3D Cervical Interbody Fusion Device, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Intelivation Technologies (Plymouth Meeting, US). The FDA issued a Cleared decision on January 8, 2026, 134 days after receiving the submission on August 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K252711 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2025
Decision Date	January 08, 2026
Days to Decision	134 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.