Cleared Traditional

IdentiTi II Cervical Interbody System

K251080 · Alphatec Spine, Inc. · Orthopedic

Jul 2025

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K251080 is an FDA 510(k) clearance for the IdentiTi II Cervical Interbody System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 3, 2025, 86 days after receiving the submission on April 8, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K251080 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2025
Decision Date	July 03, 2025
Days to Decision	86 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.