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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 30 of 185

Device	Model / Reference	Registries	Class	Status
Streamline TL Spinal Fixation System	01-RS-65-30	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-85-70	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-C-95-45	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-FXL-16	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X077-0700	FDA UDI	Class II	Active
Cortera	150150-00030	FDA UDI	Class II	Active
Streamline OCT	26-BALLTIPPRBE	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-0710	FDA UDI	Class II	Unknown
Spider Cervical Plating System	N60000106	FDA UDI	Class II	Active
CONTACT ALP Anterior Lumbar Plate System	25-PUSHPIN-25	FDA UDI	Class I	Unknown
Streamline Tl Spinal Fixation System	02-XLNK-COUNT-TORQ	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X034-1487	FDA UDI	Class I	Active
Cortera	150150-25035	FDA UDI	Class II	Active
Cortera	150150-80045	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181405TL-PC	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0112-H06-STR	FDA UDI	Class II	Active
Cortera	150150-05060	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0011	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-45025	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-RL-95	FDA UDI	Class II	Unknown
Streamline OCT	26-OCP-CNTRTORQ	FDA UDI	Class I	Active
Streamline OCT	26-R2R-XLINK-S	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-55065	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-50025	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-95115	FDA UDI	Class II	Active
Streamline OCT	26-HA-40-32	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-382815	FDA UDI	Class I	Active
Irix-C Cervical Integrated Fusion System	X066-0234	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150102-95050	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-70070	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-L18-30L-TRL	FDA UDI	Class I	Unknown
Certex Spinal Fixation System	X067-0289	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60000615-DL	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0308-F06-R-STR	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-80085	FDA UDI	Class II	Active
Cortera	150151-75110	FDA UDI	Class II	Active
Cortera	150100-10050	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1337	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-382811-08TPC-STR	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-5535	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1416SD-STR	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0016	FDA UDI	Class I	Active
Cortera	150103-90060	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-95065	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-47545-DL	FDA UDI	Class II	Active
OsteoSelect (DBM) Putty 2.5cc in a Syringe	359025	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60001039	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-55-PR-50	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0281PC	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-80-90	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.