Cleared Traditional

PASS LP? Spinal System, CD Horizon? Spinal System

K213281 · Medicrea International SA · Orthopedic

Jan 2022

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K213281 is an FDA 510(k) clearance for the PASS LP? Spinal System, CD Horizon? Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medicrea International SA (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on January 5, 2022, 96 days after receiving the submission on October 1, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K213281 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 01, 2021
Decision Date	January 05, 2022
Days to Decision	96 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.