Cleared Traditional

PERLA? TL Posterior Osteosynthesis System

K213470 · Spineart · Orthopedic

Jan 2022

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K213470 is an FDA 510(k) clearance for the PERLA? TL Posterior Osteosynthesis System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on January 21, 2022, 85 days after receiving the submission on October 28, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K213470 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2021
Decision Date	January 21, 2022
Days to Decision	85 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.