Cleared Special

Curiteva Porous PEEK Laminoplasty System

K243137 · Curiteva, Inc. · Orthopedic

Oct 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K243137 is an FDA 510(k) clearance for the Curiteva Porous PEEK Laminoplasty System, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on October 28, 2024, 28 days after receiving the submission on September 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K243137 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2024
Decision Date	October 28, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NQW — Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3050
Definition	This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.