FDA 510(k) Applications for Medical Device Product Code: PGM ()

FDA 510(k) Applications for Medical Device Product Code "PGM"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K181068	Globus Medical Inc.	CREO« Stabilization System, REVERE« Stabilization System	06/29/2018
K213196	Globus Medical Inc.	MARVELÖ Growing Rods	12/19/2022
K161028	K2M, Inc.	K2M Growing Spine System	07/22/2016
K191212	Medos International SARL	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System,	09/24/2019
K141509	MEDOS SARL	ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS	08/22/2014
K133904	MEDTRONIC SOFAMOR DANEK USA	CD HORIZON SPINAL SYSTEM GROWTH ROD SET	02/25/2014
K140750	MEDTRONIC SOFAMOR DANEK USA, INC.	SHILLA GROWTH GUIDANCE SYSTEM	07/17/2014
K150200	MEDTRONIC SOFAMOR DANEK USA, INCORPORATED	CD HORIZON Growth Rod Conversion Set	02/25/2015
K172979	NuVasive, Incorporated	NuVasive« Growth Rod Conversion Set	11/06/2017
K193224	SeaSpine Orthopedics Corporation	Daytona« Small Stature Growth Rod Conversion Set	02/13/2020
K142114	STRYKER CORPORATION	Xia« Growth Rod Conversion Set	10/27/2014
K180227	Zimmer Biomet Spine, Inc.	Polaris Spinal Growth System	03/15/2018