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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 21 of 185

Device	Model / Reference	Registries	Class	Status
Cortera Spinal Fixation System	150102-85035	FDA UDI	Class II	Active
Streamline OCT	26-DISTRACTOR-SM	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-332611-12	FDA UDI	Class II	Active
Fortilink-TS IBF System	65-TS-TRL32-11	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-181412P	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1251	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5540C	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0134	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382817-08PC-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-55060	FDA UDI	Class II	Active
Cortera	150152-85025	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0095	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0388	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0007	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-M16-20L	FDA UDI	Class II	Unknown
DBM Putty 5.0cc Syringe	ES395050	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1637	FDA UDI	Class II	Unknown
Cortera	150100-00035	FDA UDI	Class II	Active
Cortera	150100-55045	FDA UDI	Class II	Active
Streamline OCT	26-SETSCREW	FDA UDI	Class II	Active
Cortera	150203-60040	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-75-75	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	02-LATOFF-CDY-E	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	1509-020360	FDA UDI	Class I	Active
Streamline OCT	26-3255-OPEN-11	FDA UDI	Class II	Active
Streamline OCT	26-H2H-XLINK-XS	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000624	FDA UDI	Class II	Active
Cortera	150151-25095	FDA UDI	Class II	Active
Cortera	150152-95050	FDA UDI	Class II	Active
Spider Cervical Plating System	N60001994	FDA UDI	Class I	Active
Silex Sacroiliac Joint Fusion System	X079-0802	FDA UDI	Class II	Active
Calix Lumbar Spinal Implant System	X034-0725	FDA UDI	Class I	Active
DBM Putty 2.5cc in a Syringe	VM-50025	FDA UDI	Class II	Active
Cortera	1505-001901	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0043	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-0027	FDA UDI	Class II	Active
Cortera	150103-60030	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0610-STR	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0085	FDA UDI	Class I	Active
DBM Putty 1.0cc	A-945010	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	C066-0127	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0414	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	T080-0100-5	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150102-70045	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000629	FDA UDI	Class II	Active
X-port Minimally Invasive Set	X014-0002	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X022-0022	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-55-RR-210	FDA UDI	Class II	Unknown
Streamline MIS Spinal Fixation System	724-625	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150102-85050	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.