Cleared Traditional

Curiteva Porous PEEK Standalone ALIF System

K250845 · Curiteva, Inc. · Orthopedic

Jun 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250845 is an FDA 510(k) clearance for the Curiteva Porous PEEK Standalone ALIF System, a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II — Special Controls, product code OVD), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on June 18, 2025, 90 days after receiving the submission on March 20, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K250845 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2025
Decision Date	June 18, 2025
Days to Decision	90 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.