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Xtant Medical Holdings, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 664 Cruiser Lane, Belgrade, MT, 59714
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005031160
DUNS Number: —

Catalogue (9214)

Page 10 of 185

Device	Model / Reference	Registries	Class	Status
Axle Interspinous Fusion System	X080-423015-12X	FDA UDI	Class II	Active
Streamline OCT	26-CC-PB-ROD-30	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-RL-50	FDA UDI	Class II	Unknown
OsteoSelect PLUS DBM Putty 2.5cc	309425	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-90105	FDA UDI	Class II	Active
Calix Spinal Implant System	C034-0014	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0752	FDA UDI	Class I	Active
Aranax Anterior Cervical Plating System	T086-1531	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150100-15020	FDA UDI	Class II	Active
Cortera	150152-50030	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332619-12T-STR	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0306-H06-LU-STR	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	X063-0066	FDA UDI	U	Active
Fortex Pedicle Screw System	X064-0081	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0310-H04-RU	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C010-0084	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181406TP-PC	FDA UDI	Class II	Active
Cortera	150100-50025	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-5540SDX	FDA UDI	Class II	Active
Spider Cervical Plating System	N60001512	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-423013-12	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0105	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-0600	FDA UDI	Class I	Active
DBM Putty 10.0cc	GRA-P10	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0208-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0656	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-0099	FDA UDI	Class I	Active
Fixcet Spinal Facet Screw System	X063-0040	FDA UDI	U	Active
Xspan Laminoplasty Fixation System	X085-0210-F06-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0103-DL	FDA UDI	Class II	Active
Cortera	150150-60025	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-THANDLE	FDA UDI	Class I	Unknown
Zyfix Spinal Facet Screw System	T076-0108	FDA UDI	U	Active
Streamline TL Spinal Fixation System	01-PA-70-30	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	T080-423015-12TR	FDA UDI	Class I	Active
Fortilink-TS IBF System	65-TS-T26-12-12L	FDA UDI	Class I	Unknown
Irix-A Lumbar Integrated Fusion System	X080-5535STX	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0034	FDA UDI	Class II	Unknown
Cortera	150150-50050	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	51-AUTODILATE	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-20120	FDA UDI	Class II	Active
Streamline OCT	23-CC-ROD-110	FDA UDI	Class II	Active
Fortilink-TS IBF System	65-TS-8-22	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-M10-8L-TRL	FDA UDI	Class I	Unknown
Cortera	1505-010700	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-80070	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-332619-08TPC-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0099	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-55-PR-90	FDA UDI	Class II	Unknown
Contact ALP	25-60-36	FDA UDI	Class II	Active

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 9, 2026	Z-1897-2026	—	open, classified	Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.
Feb 18, 2026	Z-1773-2026	—	open, classified	Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
Jan 3, 2025	Z-1177-2025	—	open, classified	Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Aug 21, 2024	Z-0125-2025	—	open, classified	Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Nov 28, 2023	Z-0846-2024	—	open, classified	Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.