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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 3 of 185

Device	Model / Reference	Registries	Class	Status
Irix-A Lumbar Integrated Fusion System	T080-382817-20TR	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150100-60020	FDA UDI	Class II	Active
Fortilink-C	65-C-1012-6-6L	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	1509-020290	FDA UDI	Class I	Active
Cortera	1505-000120	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150102-00060	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	C079-0265	FDA UDI	Class I	Active
Cortera	150104-25070	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0009	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000405	FDA UDI	Class II	Active
Streamline OCT	26-HA-35-30	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-1233	FDA UDI	Class II	Active
Axle Interspinous Fusion System	X060-0180	FDA UDI	Class II	Active
Axle Interspinous Fusion System	C060-0097	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-PA-C-65-90	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-90090	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-20065	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-RS-C-45-30	FDA UDI	Class II	Unknown
Fortilink-A IBF System	65-A-INSERTER-A	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-382817-12TPC	FDA UDI	Class II	Unknown
Xspan Laminoplasty Fixation System	X085-0312-H04-LU-STR	FDA UDI	Class II	Active
Certex Spinal Fixation System	C067-0014	FDA UDI	Class II	Unknown
Cortera	150103-50035	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-7555	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-FX-45CDY-E	FDA UDI	Class I	Unknown
Cortera	150151-15075	FDA UDI	Class II	Active
Streamline® TL Spinal Fixation System	02-SCREWINSRTR-C	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150201-60115	FDA UDI	Class II	Active
Cortera	150152-50035	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	51-CSFINDER	FDA UDI	Class I	Unknown
Xspan Laminoplasty Fixation System	T085-0011	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0284PC-STR	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-3516ST	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X022-0017	FDA UDI	Class II	Active
Cortera	150103-55060	FDA UDI	Class II	Active
Cortera	150104-20080	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-20075	FDA UDI	Class II	Active
Cortera	150100-75035	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-85-80	FDA UDI	Class II	Unknown
Cortera	150104-80090	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-FXL-37	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-6530-DL	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0007PC	FDA UDI	Class II	Active
Cervalign	66-VST-40-16	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181409P	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5545C-DL	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-0075-S	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1319	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0347	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	04-55-PR-65	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.