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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 18 of 185

Device	Model / Reference	Registries	Class	Status
Irix-C Cervical Integrated Fusion System	X066-181407TL-PC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150150-50020	FDA UDI	Class II	Active
Streamline OCT	26-PA-SS-35-20	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	X092-0002	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X003-4011	FDA UDI	Class I	Active
Cortera	150150-80030	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-47535	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5530C-DL	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-S14-14L	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1502	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	T080-423017-20TR	FDA UDI	Class I	Active
Cortera	1505-010550	FDA UDI	Class I	Active
Cortera	150100-45040	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0758	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0677	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-1537	FDA UDI	Class I	Active
Calix Spinal Implant System	X003-0032	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150201-55150	FDA UDI	Class II	Active
Contact ALP	25-60-30	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332619-16T-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1600LM	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0276	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-0850	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0921	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	T080-423017-12TR	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0177PC	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0392LM	FDA UDI	Class II	Unknown
Fortilink-C IBF System	65-C-TRL-L-5-6L	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	722-389	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	02-GOUGE	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150101-85025	FDA UDI	Class II	Active
Cortera	1505-002581	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0112PC	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-75-30	FDA UDI	Class II	Unknown
Cortera	150104-15105	FDA UDI	Class II	Active
Butrex Buttress Plating System	X023-0022	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-90120	FDA UDI	Class II	Active
Cortera	150104-20085	FDA UDI	Class II	Active
Fortex Pedicle Screw System	N60001099	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7545-DL	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0308-F06-R	FDA UDI	Class II	Active
Atrix-C Cervical Allograft Spacer	T073-0200	FDA UDI	Class I	Active
Cortera	150100-25060	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0318	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-95-100	FDA UDI	Class II	Unknown
DBM Putty 2.5cc	A-945025	FDA UDI	Class II	Active
Cortera	150104-10070	FDA UDI	Class II	Active
Cortera	1506-2910350	FDA UDI	Class I	Active
Cortera	150151-80110	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-90-70	FDA UDI	Class II	Unknown

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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.