Cleared Traditional

Curiteva Laminoplasty System

K231232 · Curiteva, Inc. · Orthopedic

Jun 2023

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K231232 is an FDA 510(k) clearance for the Curiteva 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 June 28, 2023, 61 days after receiving the submission on April 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K231232 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2023
Decision Date	June 28, 2023
Days to Decision	61 days
Submission Type	Traditional
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.