Xtant Medical Holdings, Inc.

FDA Device Registration & Listing · Belgrade, MT, US · Registration 3005031160

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005031160
FEI Number
3005031160
Entity Name
Xtant Medical Holdings, Inc.
City/State/Country
Belgrade, MT, US
Establishment Address
664 Cruiser Lane, Belgrade, MT 59714, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Xtant Medical Holdings, Inc. (Owner Number: 10028385)
Owner / Operator Contact Address
664 Cruiser Lane, Belgrade, MT 59714, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K131951
PMA Number
N/A

All Registered Proprietary Names

Cross-Fuse II PEEK IBF System nanOss 3D Plus Advanced Bone Graft Substitute nanOss 3D Advanced Bone Graft Substitute CervAlign Lat-Fuse Lateral Plate System Zyfix Spinal Facet Screw System OsteoSelect Clamp Tamp Cequence Anterior Cervical Plate System PAC Anterior Cervical Plate Awl Streamline MIS Spinal Fixation System Calix PC Spinal Implant System Xpress Pedicle Screw System Fortex Pedicle Screw System Streamline MIS Spinal Fixation System Streamline TL Spinal Fixation System Rasp Bone Tap Irix-C Cervical Integrated Fusion System Wrench Handle Pliers Drill Brace Silex Sacroiliac Joint Fusion System Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology Spider Cervical Plating System MaxFuse PEEK VBR Calix Lumbar Spinal Implant System Cortera Spinal Fixation System Streamline OCT Occipito-Cervico-Thoracic System Tissue Shield Instrument Guide Xspan Laminoplasty Fixation System Fixcet Spinal Facet Screw System Cervalign Anterior Cervical Plate System nanOss Loaded Advanced Bone Graft Substitute nanOss Advanced Bone Graft Substitute Streamline OCT Occipito-Cervico-Thoracic System OsteoSelect Influx ProSpace BEAST Reficio VIA CuriGraft Hero GTR Axle Interspinous Fusion System Drill Bit PAC Anterior Cervical Plate Silex Sacroiliac Joint Fusion System Irix-A Lumbar Integrated Fusion System Streamline OCT Guide Needle Needle Guide Pin Cortera Quantum Spinal Fixation System Fortex Pedicle Screw System Calix-C Cervical Interbody Spacer Aspect Anterior Cervical Plate System SlimFuse Anterior Cervical Plate System Contact ALP Axle PEEK Interspinous Fusion System Calix Spinal Implant System TiPlus Forceps Elevator Trial Sizer Template Quantum Spinal Fixation System Calix Lumbar Spinal Implant System Rongeur Surgical Tray Quantum Spinal Fixation System Wire cutter Rod cutter Adaptor, 1/4" Square/Jacobs Chuck Scalpel Handle Axle-X Interspinous Fusion System Unison-C Anterior Cervical Fixation System BiomaX Aranax Anterior Cervical Plating System PAC Anterior Cervical Plate Extractor Distractor Quantum Spinal Fixation System Streamline TL Spinal Fixation System Quantum Spinal Fixation System Pin Driver Cequence Anterior Cervical Plate System Osteotome Screwdriver Compressor Dissector Quantum Spinal Fixation System Curette Contact IBF System Aspect Anterior Cervical Plate System Fortilink®-TS IBF System Fortilink®-C IBF System Fortilink® IBF System with TETRAfuse®3D Technology Fortilink®-L I BF System Mallet Streamline TL Spinal Fixation System OsteoPore Plus OsteoSelect, OsteoSelect Plus Influx Plus Reficio MAXX Fuse VIA BEAST Broach Irix-C Cervical Integrated Fusion System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-01-08
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-01-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-11-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-10-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-20
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2013-12-06
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2018-12-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-31
HXD Clamp General, Plastic Surgery Class 1 878.4800 2014-04-17
HXG Tamp Orthopedic Class 1 888.4540 2014-04-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-20
HWJ Awl Orthopedic Class 1 888.4540 2014-04-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-02-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-02-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-02-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2011-12-21
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2011-12-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-12-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-12-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-02-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-04-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-04-13
HTR Rasp General, Plastic Surgery Class 1 878.4800 2014-04-17
HWX Tap, Bone Orthopedic Class 1 888.4540 2014-04-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-11-28
HXC Wrench Orthopedic Class 1 888.4540 2014-04-17
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2014-04-17
HXY Brace, Drill Orthopedic Class 1 888.4540 2014-04-17
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2013-04-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-08-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-08-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-11-27
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-01-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-11-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-09-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-02-20
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2014-04-17
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2016-03-15
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2011-01-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-20
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-11-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-02-20
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2018-12-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2014-04-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-20
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2018-06-18
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-04-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-10-05
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2023-10-05
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2014-04-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-10-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-11-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-11-27
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-11-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-10-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-12-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2009-12-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2009-12-03
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-10-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-10-05
HTD Forceps General, Plastic Surgery Class 1 878.4800 2015-09-09
HTE Elevator General, Plastic Surgery Class 1 878.4800 2014-04-17
HWT Template Orthopedic Class 1 888.4800 2014-04-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-11-27
HTX Rongeur Orthopedic Class 1 888.4540 2015-08-24
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2014-04-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2014-04-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-12-09
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2015-08-24
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2014-01-11
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2024-01-08
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2023-10-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-10-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-09-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-20
HWB Extractor Orthopedic Class 1 888.4540 2014-04-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-08-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-08-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-08-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-08
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2014-04-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2014-04-17
HXX Screwdriver Orthopedic Class 1 888.4540 2014-04-17
HWN Instrument, Compression Orthopedic Class 1 888.4540 2014-04-17
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-04-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-01-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-01-08
HTF Curette General, Plastic Surgery Class 1 878.4800 2014-04-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-02-20
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-02-20
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2024-02-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-01-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-08-05
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-08-05
HXL Mallet General, Plastic Surgery Class 1 878.4800 2014-04-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-08-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-08-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-08-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-08-11
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2018-12-31
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-31
HTQ Broach Orthopedic Class 1 888.4540 2014-04-17
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-12-06

Official Correspondent

Rebecca Lennemann

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xtant Medical Holdings, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K223430 Life Spine, Inc. ProLift Micro Expandable Spacer System 2023-05-04
K102293 Globus Medical, Inc. CALIBER SPACER 2011-01-05
K193541 Nu Vasive, Incorporated NuVasive Cohere Thoracolumbar Interbody System 2020-03-30
K080401 Advanced Medical Technologies AG SHELL CAGE, WAVE CAGE, LOOP CAGE 2008-05-09
K200084 Zavation Medical Products, LLC Zavation IBF System 2020-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2012 X Spine Systems Inc 1
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005031160. Last updated year: 2026. Please use registration number 3005031160 when referencing this establishment in official correspondence.
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