Is this your brand? Sign in to claim ownership.

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 27 of 185

Device	Model / Reference	Registries	Class	Status
Irix-C Cervical Integrated Fusion System	X066-0250PC-CS	FDA UDI	Class I	Active
Certex Spinal Fixation System	X067-1635	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150102-20055	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-0233PC	FDA UDI	Class I	Active
Silex Sacroiliac Joint Fusion System	X079-1265-DT	FDA UDI	Class II	Active
Cortera	150151-15090	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-75100	FDA UDI	Class II	Active
Cortera	1506-2910500	FDA UDI	Class I	Active
Streamline TL Spinal Fixation System	01-LOCO-20	FDA UDI	Class II	Unknown
Contact ALP	25-SP-42	FDA UDI	Class II	Active
Fortilink-A IBF System	65-A-L16-8L	FDA UDI	Class II	Unknown
Streamline OCT	26-PA-40-44	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-65-50	FDA UDI	Class II	Unknown
Streamline® TL Spinal Fixation System	02-RAPIDREDUCR	FDA UDI	Class I	Unknown
Calix Spinal Implant System	X034-0288PC-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-65-40	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-5550	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	T066-0057	FDA UDI	Class I	Active
Silex Sacroiliac Joint Fusion System	X079-0097	FDA UDI	Class I	Active
Calix Spinal Implant System	X034-0393	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382811-12-STR	FDA UDI	Class II	Active
Cortera	1506-2950400	FDA UDI	Class I	Active
Cortera	150151-20095	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1205	FDA UDI	Class I	Active
Calix Spinal Implant System	X003-4007	FDA UDI	Class I	Active
Fortilink-TS IBF System	65-TS-TRL26-9	FDA UDI	Class II	Unknown
Streamline OCT	26-S-FINDER	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-382811-12-STRX	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150100-00020	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150306-55601	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-55080	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5530SD	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-45-20	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1628	FDA UDI	Class II	Unknown
Irix-A Lumbar Integrated Fusion System	X080-423019-12TPC	FDA UDI	Class II	Unknown
Axle Interspinous Fusion System	X060-1060	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1542	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-6530	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	C080-0075	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150106-10090	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-80080	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-80090	FDA UDI	Class II	Active
Cortera	150151-90095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150105-75070	FDA UDI	Class II	Active
Cortera	1506-2930350	FDA UDI	Class I	Active
Cortera	150151-70100	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-85-60	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-85-100	FDA UDI	Class II	Unknown
Silex Sacroiliac Joint Fusion System	X079-1230	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-10110	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.