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 9 of 185

Device	Model / Reference	Registries	Class	Status
Streamline OCT	26-PA-40-38	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-1174	FDA UDI	Class I	Active
Axle Interspinous Fusion System	X060-0813	FDA UDI	Class II	Active
X90 Pedicle Screw System	N60000513	FDA UDI	Class II	Active
Xpress Minimally Invasive Pedicle Screw System	X073-7585	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	02-HOOKPUSHER	FDA UDI	Class I	Unknown
Cortera Spinal Fixation System	150101-85055	FDA UDI	Class II	Active
VIA DBM Plus, 10cc	VX-EP10	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150107-05065	FDA UDI	Class II	Active
Streamline OCT	26-OCPS-525-8	FDA UDI	Class II	Active
Cortera	150203-55120	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5535C	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150102-90035	FDA UDI	Class II	Active
Cortera	150100-45025	FDA UDI	Class II	Active
Certex Spinal Fixation System	X067-1629LM	FDA UDI	Class II	Unknown
Streamline OCT	26-PA-45-38	FDA UDI	Class II	Active
Aranax Anterior Cervical Plating System	X086-1125-STR	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-65-70	FDA UDI	Class II	Unknown
Streamline TL Spinal Fixation System	10-55-RH-600	FDA UDI	Class II	Unknown
Calix Spinal Implant System	X034-0179	FDA UDI	Class II	Active
Cortera	150104-70120	FDA UDI	Class II	Active
Cortera	150150-75025	FDA UDI	Class II	Active
Butrex Buttress Plating System	X023-0100	FDA UDI	Class I	Unknown
Cervalign	66-230	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0395	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0176PC	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-75-45	FDA UDI	Class II	Unknown
Fortex Pedicle Screw System	X064-0003-DL	FDA UDI	Class II	Active
Silex Sacroiliac Joint Fusion System	C079-0056	FDA UDI	Class I	Active
Streamline MIS Spinal Fixation System	05-PA-65-55	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150105-20075	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-00090	FDA UDI	Class II	Active
Cortera	150100-45035	FDA UDI	Class II	Active
Calix Spinal Implant System	X034-0332PC	FDA UDI	Class II	Active
Streamline OCT	23-RATCHET-AO	FDA UDI	Class I	Active
X90 Pedicle Screw System	N60000413	FDA UDI	Class II	Active
Cortera	150104-65075	FDA UDI	Class II	Active
Cortera Spinal Fixation System	150106-65075	FDA UDI	Class II	Active
Fortex Pedicle Screw System	X064-5545-DL	FDA UDI	Class II	Active
Influx Plus Flow 1.0cc - Syringe	IFLX-FW-01	FDA UDI	Class II	Active
ProSpace™ DBM Moldable Putty (Jar)	ME916	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	04-PA-65-30	FDA UDI	Class II	Unknown
Cortera	150152-45035	FDA UDI	Class II	Active
Streamline TL Spinal Fixation System	10-RODWRENCH	FDA UDI	Class I	Unknown
Fortilink-TS IBF System	65-TS-17-22	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150107-70095	FDA UDI	Class II	Active
Streamline MIS Spinal Fixation System	05-PA-75-85	FDA UDI	Class II	Unknown
Cortera Spinal Fixation System	150102-15020	FDA UDI	Class II	Active
Streamline OCT	26-FTAP-35-10	FDA UDI	Class I	Active
Cortera	150150-25055	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.