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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 6 of 185

Device	Model / Reference	Registries	Class	Status
Streamline OCT	26-PA-SS-40-48	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0993	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-6030LX	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0630	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	C080-0022	FDA UDI	Class I	Active
Streamline® MIS Spinal Fixation System	05-CT-TUBE	FDA UDI	Class I	Unknown
Streamline MIS Spinal Fixation System	05-PA-85-90	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	T080-0070	FDA UDI	Class I	Active
OsteoSelect PLUS DBM Putty 2.5cc in a Syringe	359425	FDA UDI	Class II	Active
DBM Putty 2.5cc	BM895025	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0111	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-75-55	FDA UDI	Class II	Unknown
Cortera	1505-031250	FDA UDI	Class I	Active
VIA DBM Putty, 10cc	DBM010	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	724-263	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150102-50050	FDA UDI	Class II	Active
Fortilink-TS IBF System	65-TS-TRL22-11	FDA UDI	Class II	Unknown
Fixcet Spinal Facet Screw System	X063-0007	FDA UDI	U	Active
Irix-C Cervical Integrated Fusion System	T066-0054	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150204-55200	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-75-95	FDA UDI	Class II	Unknown
Cortera	150203-60025	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1254-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0705	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0310-F06-L	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0103-DL	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-85-95	FDA UDI	Class II	Unknown
Fortilink-TC IBF System	65-TC-T26-12-12L	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150101-50040	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-55-40	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-2883	FDA UDI	Class I	Active
Calix Spinal Implant System	C034-0205	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0380	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	X085-0108-H06	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-423015-16TR	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0255	FDA UDI	Class II	Unknown
Contact ALP	25-SP-34	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000610-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-80050	FDA UDI	Class II	Active
Fortilink-C IBF System	65-C-TRL-L-11-10L	FDA UDI	Class I	Unknown
H-graft Interspinous Allograft	X078-0007	FDA UDI	Class I	Active
Fortilink-C IBF System	65-C-TRL-M-8-10L	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150106-05110	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-65045	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-65035	FDA UDI	Class II	Active
Zyfix Spinal Facet Screw System	X076-0031	FDA UDI	U	Active
Certex Spinal Fixation System	X067-0040	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-FX-65-40	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-161306P-PC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-60160	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.