Cleared Traditional

IdentiTi? II ALIF Standalone Interbody System; Transcend? ALIF Standalone Interbody System

K251575 · Alphatec Spine · Orthopedic
Sep 2025
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K251575 is an FDA 510(k) clearance for the IdentiTi? II ALIF Standalone Interbody System; Transcend? ALIF Standalone Interbody System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Alphatec Spine (Carlsbad, US). The FDA issued a Cleared decision on September 3, 2025, 104 days after receiving the submission on May 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number K251575 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date September 03, 2025
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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