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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 1 of 185

Device	Model / Reference	Registries	Class	Status
Streamline OCT	23-CC-ROD-70	FDA UDI	Class II	Active
Cortera	150100-40040	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0110-F06-SP-STR	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0310-STR	FDA UDI	Class II	Active
Cortera	150150-25045	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	T086-1666	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-2784	FDA UDI	Class I	Active
Cortera	150150-60035	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-5540SD-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150202-60400	FDA UDI	Class II	Active
Zyfix Spinal Facet Screw System	X076-0029	FDA UDI	U	Active
Certex Spinal Fixation System	X067-0450	FDA UDI	Class II	Unknown
Cortera	150150-50040	FDA UDI	Class II	Active
Fixcet Spinal Facet Screw System	X063-0003	FDA UDI	Class I	Active
Fortilink-A IBF System	65-A-S20-30L	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-RS-85-95	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-423015-08PC-STRX	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-75-100	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	X085-0310-H04-L	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-110-55	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-70080	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0112-F04-SP	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0131	FDA UDI	Class I	Active
Cortera	150104-80075	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161307TL-PC	FDA UDI	Class II	Active
Cortera	150100-80030	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0018	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-4022	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	C080-0105	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-382811-12TPC	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150101-80055	FDA UDI	Class II	Active
Cortera	150152-50055	FDA UDI	Class II	Active
CervAlign Anterior Cervical Plate System	66-CASE	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-75065	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150101-95040	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-65110	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	T080-0100-12	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0110-F06-U-STR	FDA UDI	Class II	Active
InTice™ -C Porous Ti Cervical Interbody System	X098-0110-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	C010-0068	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0308-H06-R-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0087	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0173PC-STR	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1643PC	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0122	FDA UDI	Class II	Unknown
H-graft Interspinous Allograft	X078-0100	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	X085-0112-F06-STR	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000327	FDA UDI	Class II	Active
Streamline OCT Occipito-Cervico-Thoracic System	26-STRMOCT-INS2	FDA UDI	Class I	Unknown
Xspan Laminoplasty Fixation System	X085-0310-H04-RU-STR	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.