Cleared Traditional

PERLA? TL posterior osteosynthesis system

K203506 · Spineart · Orthopedic

Jan 2021

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K203506 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 15, 2021, 46 days after receiving the submission on November 30, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K203506 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 2020
Decision Date	January 15, 2021
Days to Decision	46 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.