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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 4 of 185

Device	Model / Reference	Registries	Class	Status
Calix Spinal Implant System	X034-0931	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	C073-0087	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-6535C	FDA UDI	Class II	Active
X90 Pedicle Screw System	N607535SD	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-05105	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-012800	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150102-45035	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-050800	FDA UDI	Class I	Active
X-port Minimally Invasive Set	X014-0018	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0132	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-65085	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161311P	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	X079-0800	FDA UDI	Class II	Active
Cortera	150100-05050	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161305P	FDA UDI	Class II	Active
Cortera	150151-65085	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-85070	FDA UDI	Class II	Active
Cortera	150100-85030	FDA UDI	Class II	Active
Cortera	150104-95110	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382813-20T-STR	FDA UDI	Class II	Active
Streamline OCT	26-PA-SS-40-34	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-95045	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-45-35	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-05090	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X077-0507	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150200-60030	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-85040	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0032	FDA UDI	Class II	Active
H-graft Interspinous Allograft	X078-0050	FDA UDI	Class I	Active
Cortera	150104-80095	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0739	FDA UDI	Class I	Active
Streamline® MIS Spinal Fixation System	51-GW-500-BLUNT-SS	FDA UDI	Class II	Unknown
DBM Putty 5.0cc Syringe	DU-5PS	FDA UDI	Class II	Active
Cervalign	66-240	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-382813-08X	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	T073-0500-75	FDA UDI	Class II	Active
Cortera	150100-85050	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1070	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-7545SD	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0152	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60000627	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382813-12-STR	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-0006	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-1033	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1040	FDA UDI	Class II	Unknown
Streamline OCT	26-DEBURRER	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-FX-45-45	FDA UDI	Class II	Unknown
InTice™ -C Porous Ti Cervical Interbody System	X098-0607-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-002380	FDA UDI	Class I	Active
Cervalign	66-MODTAP-18	FDA UDI	Class I	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.