Cleared Traditional

Curiteva Pedicle Screw System

K191810 · Curiteva, Inc. · Orthopedic

Aug 2019

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K191810 is an FDA 510(k) clearance for the Curiteva Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Curiteva, Inc. (Tanner, US). The FDA issued a Cleared decision on August 28, 2019, 54 days after receiving the submission on July 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K191810 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2019
Decision Date	August 28, 2019
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.