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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 29 of 185

Device	Model / Reference	Registries	Class	Status
Spider Cervical Plating System	N60000140	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332613-12TX	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-161306TL-PC	FDA UDI	Class II	Active
Streamline OCT	26-REDUCER-2	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150201-55035	FDA UDI	Class II	Active
Cortera	150103-60025	FDA UDI	Class II	Active
Cortera	150104-25080	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0101	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-6035LX	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-6545SD-DL	FDA UDI	Class II	Active
Certex Spinal Fixation System	C067-0015	FDA UDI	Class II	Unknown
Zyfix Spinal Facet Screw System	X076-0021	FDA UDI	U	Active
Xsert Lumbar Expandable Interbody System	X092-071024	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0242	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-55125	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150203-60165	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-FX-55-40	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	02-EXP-INS-CASE-E	FDA UDI	Class I	Unknown
X90 Pedicle Screw System	N60000326	FDA UDI	Class II	Active
Cortera	150103-55055	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-55110	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	04-GWTUBE	FDA UDI	Class I	Unknown
Cortera	150151-85115	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0697	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60001575	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-7555SD	FDA UDI	Class II	Active
Cortera	150104-95120	FDA UDI	Class II	Active
Cortera	150104-65065	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0206-H06-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0633	FDA UDI	Class II	Active
Cortera	150104-70065	FDA UDI	Class II	Active
Cortera	150104-00120	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-RR-110	FDA UDI	Class II	Unknown
Xpress Minimally Invasive Pedicle Screw System	C073-0056	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-200010	FDA UDI	Class I	Active
Cortera	150150-85035	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000628-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-80090	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-0818	FDA UDI	Class I	Active
Silex Sacroiliac Joint Fusion System	C079-0044	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-2861	FDA UDI	Class I	Active
H-graft Interspinous Allograft	X078-0086	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X010-0604	FDA UDI	Class II	Active
Streamline OCT	26-PA-SS-35-36	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-85075	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-95115	FDA UDI	Class II	Active
Cortera	150203-55145	FDA UDI	Class II	Active
Cortera	150151-25115	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0263	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-95-40	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.