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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K221926	Alphatec Spine, Inc.	Invictus« Bone Cement, Invictus Spinal Fixation System	12/20/2022
K190526	CarboFix Orthopedics Ltd.	High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws	09/19/2019
K172269	Globus Medical, Inc.	FORTRESSÖ Radiopaque Bone Cement (FORTRESSÖ and FORTRESS-PlusÖ), CREO« Fenestrated Screw System, REVLOK« Fenestrated Screw System	03/27/2018
K200596	Icotec AG	G21 Cement, VADER« Pedicle System	10/13/2020
K222789	icotec ag	VADER« Pedicle System, G21 Cement	01/09/2023
K160879	Medos International Sαrl	CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems	12/20/2016
K201362	Medtronic	CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement	08/19/2020
K171938	Medtronic	KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set	10/23/2017
K152604	Medtronic Sofamor Danek USA, Incorporated	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set	01/06/2016
K191148	Medtronic Sofamor Danek, USA Inc.	Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set	09/12/2019
K212489	Neo Medical SA	BonOs Inject Bone Cement; NEO Pedicle Screw System	10/28/2021
K222256	Neo Medical SA	BonOs« Inject Bone Cement; NEO Pedicle Screw SystemÖ	08/26/2022
K180498	NuVasive, Incorporated	NuVasive Reline Fenestrated Screws, High V+ Bone Cement	11/28/2018
K230774	Spineart	PERLA« TL System; TEKTONA« HV US Bone Cement	06/23/2023
K192818	Stryker Corporation	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System	03/31/2020