X-Spine Systems, Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K173832	InTice™-C Porous Ti Cervical Interbody System	ODP	2018-05-17	View
510(k)	K180153	X-spine Cortical Bone Screw System	NKB	2018-03-15	View
510(k)	K170119	Calix Lumbar Spinal Implant System	MAX	2017-09-29	View
510(k)	K171567	IRIX-A Lumbar Integrated Fusion System	OVD	2017-08-28	View
510(k)	K171075	Calix-C Cervical Interbody Spacer	ODP	2017-08-01	View
510(k)	K170224	Spider Cervical Plating System	KWQ	2017-07-06	View
510(k)	K170530	Butrex Lumbar Buttress Plating System	KWQ	2017-03-22	View
510(k)	K160959	Xsert Lumbar Expandable Interbody System	MAX	2016-11-17	View
510(k)	K162944	Irix-C Cervical Integrated Fusion System	OVE	2016-11-07	View
510(k)	K160428	Certex Spinal Fixation System	NKG	2016-05-05	View
510(k)	K160114	Xspan Laminoplasty Fixation System	NQW	2016-03-15	View
510(k)	K133094	CERTEX OCT SPINAL IMPLANT SYSTEM	KWP	2013-12-11	View
510(k)	K131350	CALIX LUMBAR SPINAL IMPLANT SYSTEM	MAX	2013-10-23	View
510(k)	K131951	IRIX-C CERVICAL INTEGRATED FUSION SYSTEM	OVE	2013-08-14	View
510(k)	K130438	AXLE INTERSPINOUS FUSION SYSTEM	PEK	2013-06-27	View
510(k)	K123932	ZYGAFIX SPINAL FACET SCREW SYSTEM	MRW	2013-05-01	View
510(k)	K123702	SILEX SACROILIAC JOINT FUSION SYSTEM	OUR	2013-03-11	View
510(k)	K122163	CERTEX SPINAL IMPLANT SYSTEM	MNI	2012-10-31	View
510(k)	K120832	FORTEX PEDICLE SCREW SYSTEM	MNH	2012-10-23	View
510(k)	K112592	AXLE PEEK INTERSPINOUS FUSION SYSTEM	KWP	2011-12-05	View