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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 2 of 185

Device	Model / Reference	Registries	Class	Status
Axle Interspinous Fusion System	X060-0752	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0833	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000478	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150202-55600	FDA UDI	Class II	Active
CONTACT ALP Anterior Lumbar Plate System	25-PUSHPIN	FDA UDI	Class I	Unknown
Streamline TL Spinal Fixation System	01-PA-45-30	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-75100	FDA UDI	Class II	Active
Cortera	150151-85095	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0738	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0627	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-2720	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-95-90	FDA UDI	Class II	Unknown
X90 Pedicle Screw System	N60000317	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-25105	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181411TP	FDA UDI	Class II	Active
Cortera	150103-75040	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-55-30	FDA UDI	Class II	Unknown
Streamline OCT	26-CC-PB-ROD-120	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0110PC	FDA UDI	Class II	Active
OsteoSelect PLUS DBM Putty 10.0cc	309500	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-TEMPLATE-250	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X003-0042	FDA UDI	Class I	Active
Streamline® TL Spinal Fixation System	02-TAP-90	FDA UDI	Class I	Unknown
Cortera	150104-75110	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0208	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X080-423015-12TPC-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0405	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0243	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0281PC-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-80-60	FDA UDI	Class II	Unknown
Cortera	150152-60040	FDA UDI	Class II	Active
Streamline OCT	26-COUNTER-T-2	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X080-382817-12T-STR	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-0093-DL	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-70075	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-75035	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1505-051250	FDA UDI	Class I	Active
Calix Spinal Implant System	C003-0041	FDA UDI	Class I	Active
Xspan Laminoplasty Fixation System	T085-0042-10	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	C080-0055	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150101-75025	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181406P	FDA UDI	Class II	Active
Axograft Crunch 5cc	X090-0020-MX5CCS	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-65090	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-2606	FDA UDI	Class II	Active
Spider Cervical Plating System	N60001992	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7565-DL	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0012PC	FDA UDI	Class II	Active
Cortera	1505-002340	FDA UDI	Class I	Active
OsteoSelect DBM Putty 10.0cc	309100	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.