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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 22 of 185

Device	Model / Reference	Registries	Class	Status
Fortilink-A IBF System	65-A-INSERTER	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-0086-DL	FDA UDI	Class II	Active
Butrex Buttress Plating System	X023-0002	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	T080-332611-20TR	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	10-CUTCART-635	FDA UDI	Class I	Unknown
Axle Interspinous Fusion System	X060-1254	FDA UDI	Class II	Active
Cortera	150151-15065	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0126	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	X085-0112-H06	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-47530	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0121	FDA UDI	Class II	Unknown
Calix Spinal Implant System	C003-0033	FDA UDI	Class I	Active
Certex Spinal Fixation System	C067-0042	FDA UDI	Class II	Unknown
Streamline MIS Spinal Fixation System	04-PA-75-35	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0284PC	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0308-H06-RU-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-80-75	FDA UDI	Class II	Unknown
Streamline OCT	26-OCPST-45-10	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1234	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0272	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1153	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0181	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0370	FDA UDI	Class I	Active
Contact ALP	25-PALMHANDLE	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-1139	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0177	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X077-0712	FDA UDI	Class II	Active
DBM Putty 2.5cc, Axograft	X090-0015-PT2.5CC	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-10120	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161312P-PC	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-MDROD-CDY	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	10-55-PR-RL-150	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X080-332611-08TPC-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1028	FDA UDI	Class II	Unknown
Irix-C Cervical Integrated Fusion System	X066-0252PC	FDA UDI	Class I	Active
Cortera	1505-000641	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0252	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150201-55200	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0679PC	FDA UDI	Class II	Active
Certex Spinal Fixation System	C067-0044	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-115-55	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60001038-DL	FDA UDI	Class II	Active
Cortera	150100-85060	FDA UDI	Class II	Active
Cortera	1506-2910450	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-55-55	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	C060-0075	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-1211	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0310-F04-R-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-95045	FDA UDI	Class II	Active
Streamline® MIS Spinal Fixation System	04-FIXHOLDER-SCREW	FDA UDI	Class I	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.