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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K182617	Alphatec Spine, Inc	ATEC IOM Accessory Instruments	05/09/2019
K221821	Alphatec Spine, Inc.	ATEC IOM Accessory Instruments	09/23/2022
K191723	Alphatec Spine, Inc.	ATEC IOM Accessory Instruments	10/18/2019
K132373	BIOMET SPINE (AKA EBI, LLC)	BIOMET ACCESS SYSTEM	03/27/2014
K182662	Boston Endo Surgical Tech,	NAV PAK Needle, NIM NAV PAK Needle	04/10/2019
K180542	Boston Endo Surgical Tech,	NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe	08/22/2018
K123589	CADWELL	CADWELL DISPOSABLE PROBE HANDLE	03/19/2013
K131304	INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS")	SENTIO MMG	05/29/2014
K120590	KOROS USA, INC.	DILATOR TUBE SET	05/07/2013
K181559	Magstim Company Ltd.	Neurosign V4 Intraoperative Nerve Monitor	11/09/2018
K203684	Magstim Company Ltd.	Neurosign V4 Intraoperative Nerve Monitor	03/17/2021
K173134	Medos International SARL	SENTIO MMG Pedicle Access Needles	03/22/2018
K173526	Medos International, SARL	SENTIO MMG Gen 2	04/05/2018
K223438	Medos International, SARL	TELIGEN System Peripheral Motor Nerve Stimulation Indications	02/10/2023
K130806	NEUROVISION MEDICAL PRODUCTS, INC.	NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE	07/12/2013
K162313	NUVASIVE INCORPORATED	NuVasive Next Generation NVM5 System	03/16/2017
K152942	NUVASIVE INCORPORATED	NuVasiveNVM5 System	01/13/2016
K123307	NUVASIVE, INC.	NUVASIVE NVM5 SYSTEM	04/23/2013
K141968	NUVASIVE, INC.	NUVASIVE NVM5 SYSTEM	11/14/2014
K133530	NUVASIVE, INCORPORATED	NUVASIVE EMG ENDOTRACHEAL TUBE	05/02/2014
K143641	NuVasive, Incorporated	NuVasive NVM5 System	03/27/2015
K132694	NUVASIVE, INCORPORATED	NUVASIVE NVM5 SYSTEM	05/16/2014
K142438	Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.)	Nerve Monitoring Cable System	03/05/2015
K132138	RHYTHMLINK INTERNATIONAL, LLC	RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE	04/11/2014
K161893	SI-BONE, INC.	Neuromonitoring Kit	10/18/2016
K220160	Spine Guard S.A.	PediGuard Threaded	03/31/2022
K143159	SpineGuard, S.A.	Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ╪4.0mm, PediGuard Tri Tip ╪3.2mm, PediGuard Tri Tip ╪2.5mm, PediGuard ╪2.5mm XS, PediGuard Curv, PediGuard Curv	01/23/2015
K201454	SpineGuard, S.A.	DSG Connect Technology	02/10/2021
K152747	SPINEGUARD, S.A.	DSG Threaded Drill System	06/10/2016
K123390	SPINEGUARD, S.A.	PEDIGUARD NERVE DETECTOR SYSTEM	08/08/2013
K171807	Stryker Corporation	ES2 Neuromonitoring Accessory Instruments	07/18/2017
K190163	SurGenTec, LLC	ALARA Neuro Access Kit	07/16/2019
K140088	TEDAN SURGICAL INNOVATIONS, LLC	PHANTOM XL INSULATED DILATORS	09/25/2014