Cleared Special

Curiteva Porous PEEK Cervical Interbody Fusion System

K254061 · Curiteva, Inc. · Orthopedic

Jan 2026

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K254061 is an FDA 510(k) clearance for the Curiteva Porous PEEK Cervical Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Cervical (Class II — Special Controls, product code ODP), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on January 15, 2026, 29 days after receiving the submission on December 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K254061 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2025
Decision Date	January 15, 2026
Days to Decision	29 days
Submission Type	Special
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.