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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222097	Astura Medical	OLYMPIC Deformity Band System	05/04/2023
K172206	Cousin Biotech S.A.S.	NAJAÖ Ligament Correction System	04/10/2018
K181799	Cousin Biotech S.A.S.	ResCUBEÖ Ligament Fixation System	08/29/2018
K230565	Globus Medical Inc.	HILINEÖ Fixation System	04/20/2023
K172417	Globus Medical Inc.	SILC« Fixation System	10/26/2017
K133482	GLOBUS MEDICAL, INC.	SILC FIXATION SYSTEM	05/21/2014
K132287	HOGAN LOVELLS US LLP	JAZZ SYSTEM	09/25/2013
K133617	IMPLANET S.A.	JAZZ SYSTEM	02/20/2014
K143759	IMPLANET S.A.	JAZZ System	05/07/2015
K153348	Implanet, S.A.	JAZZ LOCK	03/31/2016
K171881	Implanet, S.A.	JAZZ Passer Band	08/08/2017
K191217	Implanet, S.A.	JAZZ PF	08/02/2019
K151740	Implanet, S.A.	JAZZ System	08/27/2015
K170730	Implanet, S.A.	JAZZ System, including JAZZ Band	06/09/2017
K143350	K2M, Inc.	Nile Alternative Fixation	02/25/2015
K160208	K2M, Inc.	NILE Alternative Fixation Spinal System	03/18/2016
K161332	K2M, INC.	NILE Proximal Fixation Spinal System	04/05/2017
K132395	MEDICREA INTERNATIONAL	LIGAPASS	12/06/2013
K213659	Medicrea International S. A.	LigaPASSÖ 2.0 Ligament Augmentation System	05/24/2022
K160698	MEDICREA INTERNATIONAL S.A.	LigaPASS	09/02/2016
K172021	Medicrea International S.A.	LigaPASS	08/30/2017
K173506	Medicrea International S.A.	LigaPASS	04/03/2018
K163181	Medtronic Sofamor Danek USA, Inc.	TRANSLACEÖ Spinal Tethering System	05/16/2017
K211057	Medtronic, Inc.	LigaPASS« Spinal System, CD HorizonÖ Spinal System	05/27/2021
K173117	NuVasive, Inc.	NuVasive« VersaTieÖ System	12/07/2017
K161265	NUVASIVE, INCORPORATED	NuVasive« VersaTie System	07/15/2016
K190418	NuVasive, Incorporated	NuVasive« VersaTie« System	03/21/2019
K200281	Ortho Development Corporation	The Gecko Spinal System	03/31/2020
K161267	ORTHOPEDIATRICS CORP.	Response BandLoc Spinal Fixation	08/11/2016
K200097	OrthoPediatrics Corp.	Response BandLoc Spinal Fixation	03/16/2020
K201240	SeaSpine Orthopedics Corporation	Mariner Cap System	08/05/2020
K190289	Spinal Elements Inc	Karma« Fixation System	04/03/2019
K180728	Spinal Elements Inc	Spinal Elements Cerclage System	09/06/2018
K110348	ZIMMER SPINE	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	08/11/2011
K142053	ZIMMER SPINE, INC.	UNIVERSAL CLAMP SPINAL FIXATION SYSTEM	10/29/2014