FDA 510(k) Applications for Medical Device Product Code: ONN (Intraoperative Orthopedic Joint Assessment Aid)

FDA 510(k) Applications for Medical Device Product Code "ONN"
(Intraoperative Orthopedic Joint Assessment Aid)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K132104	Kamm & Associates	ELIBRA SOFT-TISSUE FORCE SENSOR	03/21/2014
K090474	ORTHOSENSOR, INC.	ORTHOREX INTRA-OPERATIVE LOAD SENSOR	10/19/2009
K130380	ORTHOSENSOR, INC.	ORTHOSENSOR KNEE BALANCER	06/13/2013
K131767	ORTHOSENSOR, INC.	ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM	11/08/2013
K200587	OrthoSensor, Inc.	VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder	08/25/2020
K200665	OrthoSensor, Inc.	VERASENSE for Stryker Triathlon	04/12/2020
K180459	OrthoSensor, Inc.	VERASENSE for Zimmer Biomet Persona	06/07/2018
K193580	OrthoSensor, Inc.	VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR	04/01/2020
K150372	OrthoSensor, Inc.	VERASENSE Knee System	04/15/2016
K070108	SYNVASIVE TECHNOLOGY, INC.	ELIBRA DYNAMIC KNEE BALANCER	04/04/2007
K093046	SYNVASIVE TECHNOLOGY, INC.	ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES	03/22/2011
K220830	These Three Medical, LLC	TrueBalanceÖ Surgical System	09/15/2022
K162237	XPANDORTHO, INC.	XO1 Knee Balancing System	04/25/2017