Cleared Traditional

Curiteva Porous PEEK Lumbar Interbody Fusion System

K233744 · Curiteva, Inc. · Orthopedic

Jan 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K233744 is an FDA 510(k) clearance for the Curiteva Porous PEEK Lumbar Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on January 18, 2024, 57 days after receiving the submission on November 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K233744 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2023
Decision Date	January 18, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.