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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K153446	Astura Medical	OLYMPIC Posterior Spinal Fixation System	04/08/2016
K131615	BIOMET SPINE (AKA EBI, LLC)	POLARIS SPINAL SYSTEM	09/04/2013
K131802	DEPUY SPINE, A JOHNSON & JOHNSON COMPANY	EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM	09/12/2013
K124058	GLOBUS MEDICAL INC.	CREO STABILIZATION SYSTEM	05/13/2013
K132303	IMPLANET S.A.	IMPLANET SPINE SYSTEM	10/10/2013
K121630	K2M, INC.	RANGE SPINAL SYSTEM	09/11/2012
K131030	K2M, INC.	RANGE SPINAL SYSTEM	05/09/2013
K130330	K2M, INC.	RANGE SPINAL SYSTEM	05/02/2013
K131784	K2M, INC.	RANGE SPINAL SYSTEM	08/30/2013
K122877	K2M, INC.	RANGE SPINAL SYSTEM, SMALL STATURE	05/08/2013
K123412	K2M, INC.	RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS	02/13/2013
K123138	MEDICREA INTERNATIONAL	PASS LP SPINAL SYSTEM	02/05/2013
K132574	MEDICREA INTERNATIONAL	PASS LP SPINAL SYSTEM	11/08/2013
K132575	MEDICREA INTERNATIONAL	PASS LP SPINAL SYSTEM	10/03/2013
K140276	MEDTRONIC SOFAMOR DANEK	CD HORIZON SPINAL SYSTEM	03/13/2014
K131321	MEDTRONIC SOFAMOR DANEK USA	CD HORIZON SPINAL SYSTEM	06/05/2013
K120291	ORTHOPEDIATRICS, CORP.	OP SPINE SYSTEM	04/16/2012
K121250	ORTHOPEDIATRICS, CORP.	OP SPINE SYSTEM	06/19/2012
K130655	ORTHOPEDIATRICS, CORP.	RESPONSE SPINE SYSTEM	05/08/2013