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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 11 of 185

Device	Model / Reference	Registries	Class	Status
X90 Pedicle Screw System	N605545SD	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150205-55500	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150201-60120	FDA UDI	Class II	Active
Cortera	1506-2930550	FDA UDI	Class I	Active
Cortera	150151-70120	FDA UDI	Class II	Active
Cortera	1505-000110	FDA UDI	Class I	Active
Fortex Pedicle Screw System	X064-7530	FDA UDI	Class II	Active
Xspan Laminoplasty Fixation System	X085-0106-SP-STR	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-C-45-35	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	01-PA-105-80	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0033	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1372-STR	FDA UDI	Class II	Active
Cortera	1505-003100	FDA UDI	Class I	Active
Irix-A Lumbar Integrated Fusion System	X080-423017-20PC-STR	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-332615-08-STRX	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-161311L	FDA UDI	Class II	Active
Calix Spinal Implant System	X003-0286	FDA UDI	Class I	Active
Cortera Spinal Fixation System	150102-00035	FDA UDI	Class II	Active
Cervalign	66-FST-40-18	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-75-100	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	1509-210040	FDA UDI	Class I	Active
Cortera	150200-55150	FDA UDI	Class II	Active
Cortera Spinal Fixation System	1509-020250	FDA UDI	Class I	Active
Cortera	150151-05065	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0048	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-0400LM	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X077-0411	FDA UDI	Class II	Active
Cortera	150152-65030	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	T073-0700	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150209-55095	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150203-55185	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-CUTCART-60	FDA UDI	Class I	Unknown
Cortera	150104-05080	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382813-12T	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	725-096	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150107-20070	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-75050	FDA UDI	Class II	Active
Streamline OCT	26-HA-40-42	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-7545-DL	FDA UDI	Class II	Active
Irix-A Lumbar Integrated Fusion System	X080-382819-24PC-STR	FDA UDI	Class II	Active
Irix-C Cervical Integrated Fusion System	X066-181411P	FDA UDI	Class II	Active
Fortilink-TC IBF System	65-TC-T32-11-12L	FDA UDI	Class I	Unknown
Reficio DBM Putty 5cc	27800418	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150204-55035	FDA UDI	Class II	Active
Cortera	1506-2930300	FDA UDI	Class I	Active
Xpress Minimally Invasive Pedicle Screw System	C073-0072	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-0640	FDA UDI	Class II	Unknown
Certex Spinal Fixation System	X067-1710	FDA UDI	Class II	Unknown
Cortera	150152-80050	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	01-PA-65-70	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.