Cleared Traditional

Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System

K252205 · Curiteva, Inc. · Orthopedic

Jan 2026

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K252205 is an FDA 510(k) clearance for the Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF 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 16, 2026, 186 days after receiving the submission on July 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K252205 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2025
Decision Date	January 16, 2026
Days to Decision	186 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.