Xtant Medical Holdings, Inc.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005031160	3005031160	Xtant Medical Holdings, Inc.	1	Y	2026-01-01	664 Cruiser Lane Belgrade MT US 59714

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
99208	1860374125	K241892	Cortera Spinal Fixation System	NKB	2024-08-02
99208	1417285533	K221403	Cortera Spinal Fixation System	NKB	2022-08-19
99208	1082929529	K213493	Fortilink with TiPlus Technology	ODP	2022-01-27
99208	1274746097	K211408	CervAlign® Anterior Cervical Plate System	KWQ	2021-06-23
99208	1845075767	K192800	Streamline TL Spinal Fixation System	NKB	2020-01-14
99208	2030013051	K192718	Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology	MAX	2019-12-20
99208	1924775736	K192396	Streamline MIS Spinal Fixation System	NKB	2019-11-26
99208	1568669240	K190498	Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System	MAX	2019-07-05
99208	1605502435	K183060	CervAlign Anterior Cervical Plate System	KWQ	2019-01-17
99208	1183008806	K180153	X-spine Cortical Bone Screw System	NKB	2018-03-15
99208	1532119621	K173832	InTice-C Porous Ti Cervical Interbody System	ODP	2018-05-17
99208	1314738966	K172343	Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology	MAX	2017-10-23
99208	1930187067	K172139	Streamline OCT Occipito-Cervico-Thoracic System	NKG	2017-08-18
99208	1465188391	K171567	IRIX-A Lumbar Integrated Fusion System	OVD	2017-08-28
99208	1572633568	K171075	Calix-C Cervical Interbody Spacer	ODP	2017-08-01
99208	1014003321	K170830	Unison-C Anterior Cervical Fixation System	OVE	2017-06-28
99208	1994576142	K170643	Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System	MAX	2017-04-14
99208	1290315079	K170530	Butrex Lumbar Buttress Plating System	KWQ	2017-03-22
99208	1818407124	K170224	Spider Cervical Plating System	KWQ	2017-07-06
99208	1621108437	K170119	Calix Lumbar Spinal Implant System	MAX	2017-09-29
99208	1968917133	K163673	Fortilink-C with TETRAfuse 3D Technology	ODP	2017-05-23
99208	1894688998	K162944	Irix-C Cervical Integrated Fusion System	OVE	2016-11-07
99208	1950507091	K161498	Streamline OCT Occipito-Cervico-Thoracic System	NKG	2016-08-22
99208	1570260135	K160959	Xsert Lumbar Expandable Interbody System	MAX	2016-11-17
99208	1033796267	K160428	Certex Spinal Fixation System	NKG	2016-05-05
99208	1179464550	K160114	Xspan Laminoplasty Fixation System	NQW	2016-03-15
99208	1763947580	K152793	Unison-C Anterior Cervical Fixation System	OVE	2016-01-19
99208	1210496406	K152132	X-spine Pedicle Screw System	MNI	2015-09-25
99208	1648726971	K150834	Atrax Anterior Cervical Plating System	KWQ	2015-07-10
99208	1656972275	K150621	OsteoSelect PLUS Demineralized Bone Matrix Putty	MQV	2015-08-18
99208	1969332470	K150521	Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System	ODP	2015-05-15
99208	1608788248	K150254	Streamline OCT Occipito-Cervico-Thoracic System	KWP	2015-04-28
99208	1670196522	K141600	NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT	MQV	2014-10-17
99208	1319942201	K140696	STREAMLINE TL SPINAL FIXATION SYSTEM	NKB	2014-04-10
99208	1632500976	K140079	SILEX SACROILIAC JOINT FUSION SYSTEM	OUR	2014-03-25
99208	1990781055	K133947	IRIX-A LUMBAR INTEGRATED FUSION SYSTEM	OVD	2014-07-29
99208	1833964363	K133623	C-PLUS	ODP	2014-02-10
99208	2003506242	K133455	CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC	MAX	2014-03-27
99208	1685251928	K133374	STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM	KWP	2014-03-19
99208	1044565663	K133094	CERTEX OCT SPINAL IMPLANT SYSTEM	KWP	2013-12-11
99208	1104689326	K132050	NB3D BONE VOID FILLER	MQV	2014-02-07
99208	1771389983	K131951	IRIX-C CERVICAL INTEGRATED FUSION SYSTEM	OVE	2013-08-14
99208	1430442059	K131724	PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE	MQP	2013-12-24
99208	1288211208	K131350	CALIX LUMBAR SPINAL IMPLANT SYSTEM	MAX	2013-10-23
99208	1300710938	K131100	STREAMLINE TL SPINAL SYSTEM	NKB	2013-06-27
99208	1330019346	K130498	OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY	MBP	2013-05-31
99208	1886223894	K130438	AXLE INTERSPINOUS FUSION SYSTEM	PEK	2013-06-27
99208	1923494807	K130427	PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2013-06-05
99208	1661013632	K130286	STREAMLINE MIS SPINAL FIXATION SYSTEM	NKB	2013-04-01
99208	1253921616	K123932	ZYGAFIX SPINAL FACET SCREW SYSTEM	MRW	2013-05-01
99208	1630017032	K123702	SILEX SACROILIAC JOINT FUSION SYSTEM	OUR	2013-03-11
99208	1223904155	K122163	CERTEX SPINAL IMPLANT SYSTEM	MNI	2012-10-31
99208	1378051356	K120832	FORTEX PEDICLE SCREW SYSTEM	MNH	2012-10-23
99208	1375172010	K120724	PIONEER LATERAL PLATE SYSTEM	KWQ	2012-05-07
99208	1959853067	K112592	AXLE PEEK INTERSPINOUS FUSION SYSTEM	KWP	2011-12-05
99208	1538542374	K112496	PIONEER CROSSFUSE II IBF/VBR SYSTEM	MAX	2011-09-28
99208	1733929857	K112036	CALIX PC SPINAL IMPLANT SYSTEM	ODP	2011-11-08
99208	1509674905	K111528	PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES	KWQ	2011-08-24
99208	1990988046	K111502	STREAMLINE TL SPINAL SYSTEM	NKB	2011-08-23
99208	1874887874	K101790	QUANTUM SPINAL SYSTEM, QUANTUM MIS	NKB	2011-03-07
99208	1709614594	K101471	AXLE INTERSPINOUS FUSION SYSTEM	KWP	2010-11-24
99208	1457134608	K100154	FIXCET SPINAL FACET SCREW SYSTEM	MRW	2010-05-21
99208	1580977927	K093771	QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM	MNH	2010-08-10
99208	1578054670	K093692	QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES	NKB	2010-08-11
99208	1356883163	K092360	ACP4 SPINAL IMPLANT SYSTEM	KWQ	2010-01-22
99208	1102967832	K091321	OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY	MQV	2009-09-11
99208	1573953836	K090224	FORTEX PEDICLE SCREW SYSTEM	MNH	2009-07-30
99208	1972853392	K090222	PIONEER LUMBAR PLATE SYSTEM	KWQ	2009-04-28
99208	1943832824	K083663	PACP	KWQ	2009-02-25
99208	1224593319	K083637	CALIX SPINAL IMPLANT SYSTEM	ODP	2009-04-20
99208	1413015254	K082821	SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2008-10-31
99208	1318018479	K081132	SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2008-07-14
99208	1253929324	K080518	PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM	NKB	2008-03-20
99208	1084442488	K073177	PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM	MAX	2008-05-13
99208	1418025005	K072943	BUTREX BUTTRESS PLATING SYSTEM	KWQ	2008-01-28
99208	1708063581	K072703	PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM	KWQ	2008-01-10
99208	1958444735	K071849	ALLOFUSE GEL AND PUTTY	MQV	2008-12-04
99208	1694083666	K070973	QUANTUM SPINAL SYSTEM	NKB	2007-07-03
99208	1117781644	K070551	MODIFICATION TO: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM	NKB	2007-03-29
99208	1224241992	K053053	PACP SYSTEM	KWQ	2005-11-16
99208	1365577124	K052847	CAPLESS PEDICLE SCREW SYSTEM	MNI	2005-12-12
99208	1908373475	K052292	SPIDER CERVICAL PLATING (SCP) SYSTEM	KWQ	2005-10-21
99208	1922984623	K043066	PIONEER ANTERIOR CERVICAL PLATE SYSTEM	KWQ	2005-02-03
99208	1280712713	K041469	ANTERIOR COMPACT SYSTEM	KWQ	2004-07-30
99208	1668230762	K041167	PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM	NKB	2004-07-23
99208	1012249353
99208	1023110539
99208	1024502830
99208	1061730744
99208	1085233238
99208	1113514348
99208	1149963028
99208	1186304748
99208	1190609856
99208	1205274556
99208	1250104800
99208	1265900515
99208	1355927740
99208	1374432133
99208	1413461732
99208	1424773215
99208	1433747898
99208	1461834812
99208	1465994337
99208	1502322616
99208	1559830911
99208	1602087799
99208	1623632428
99208	1634110776
99208	1692566731
99208	1717562730
99208	1753189482
99208	1755342096
99208	1759306033
99208	1823074133
99208	1854353817
99208	1869407209
99208	1887543800
99208	1934485472
99208	1944248574

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
KWQ	19	2021-06-23
NKB	15	2024-08-02
MAX	10	2019-12-20
ODP	8	2022-01-27
MQV	5	2015-08-18
KWP	5	2015-04-28
OVE	4	2017-06-28
NKG	3	2017-08-18
MNI	3	2015-09-25
MNH	3	2012-10-23
OVD	2	2017-08-28
OUR	2	2014-03-25
MRW	2	2013-05-01
NQW	1	2016-03-15
MQP	1	2013-12-24
PEK	1	2013-06-27
MBP	1	2013-05-31