Cleared Special

CD Horizon? Spinal System and PASS LP? Spinal System

K220724 · Medicrea International · Orthopedic

Apr 2022

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K220724 is an FDA 510(k) clearance for the CD Horizon? Spinal System and PASS LP? Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medicrea International (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on April 8, 2022, 25 days after receiving the submission on March 14, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K220724 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2022
Decision Date	April 08, 2022
Days to Decision	25 days
Submission Type	Special
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.