Cleared Traditional

PERLA TL Posterior Osteosynthesis System

K203222 · Spineart · Orthopedic

Dec 2020

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K203222 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 December 17, 2020, 45 days after receiving the submission on November 2, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K203222 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2020
Decision Date	December 17, 2020
Days to Decision	45 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.