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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 20 of 185

Device	Model / Reference	Registries	Class	Status
Axle Interspinous Fusion System	X060-0622	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0676PC	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0193	FDA UDI	Class II	Unknown
Cortera	150152-55025	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-020050	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	C080-0083	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-75-70	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1555	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	T073-0500-825-DL	FDA UDI	Class II	Active
Fortex Pedicle Screw System	C010-0069	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	C022-0018	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0394	FDA UDI	Class II	Unknown
H-graft Interspinous Allograft	X078-0003	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-10120	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-60050	FDA UDI	Class II	Active
Cortera	1505-002502	FDA UDI	Class I	Active
Cortera	150151-85120	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-10085	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0113PC	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0211	FDA UDI	Class II	Active
Contact ALP	25-65-34	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-60110	FDA UDI	Class II	Active
Xsert Lumbar Expandable Interbody System	T092-0600-30	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-95-55	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	X073-82595	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1670	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	T066-0078	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60001037	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X010-0167	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X077-0713	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-82545-DL	FDA UDI	Class II	Active
Cortera	150150-60045	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0055	FDA UDI	Class I	Active
Cortera	150203-55085	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-6040L	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-RS-75-40	FDA UDI	Class II	Unknown
Silex Sacroiliac Joint Fusion System	C079-0037	FDA UDI	Class I	Active
Streamline® TL Spinal Fixation System	02-RS-TAB-BREAKER	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-10105	FDA UDI	Class II	Active
Streamline OCT	26-HA-35-50	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-423015-08PC-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-6595	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-65020	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0694	FDA UDI	Class I	Active
Cortera	150150-70040	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1632LM	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-332615-20T-STR	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-1419	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	T085-0015-06	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150107-95110	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.