FDA 510(k), K183091, Elaris Pedicle Screw System

510(K) Number: K183091
Device Name: Elaris Pedicle Screw System
Manufacturer: SpineWelding AG
Device Classification Name: thoracolumbosacral pedicle screw system
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 11/06/2018
Decision Date: 08/02/2019
Regulation Medical Specialty: Orthopedic

Heavily redacted