Xtant Medical Inc

FDA Filings

This page includes the latest FDA filings for Xtant Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005031160
FEI Number3005031160
NameX-SPINE SYSTEMS/Bacterin International
Owner & OperatorXtant Medical Inc.
Contact Address664 Cruiser Lane
Belgrade MT 59714 US
Official Correspondent
  • Casey Ming
  • x-406-3880480-1128
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address664 Cruiser Lane
Belgrade, MT 59714 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Xtant Medical, Inc.
nanOss 3D Plus Advanced Bone Graft Substitute 90-400-255082024-04-24
Xtant Medical, Inc.
nanOss 3D Plus Advanced Bone Graft Substitute 90-400-255042024-04-24
Xtant Medical, Inc.
nanOss 3D Plus Advanced Bone Graft Substitute 90-400-2510082024-04-24
Xtant Medical, Inc.
nanOss 3D Plus Advanced Bone Graft Substitute 90-400-2510042024-04-24
Xtant Medical, Inc.
nanOss 3D Advanced Bone Graft Substitute 90-300-255082024-04-24
Xtant Medical, Inc.
nanOss 3D Advanced Bone Graft Substitute 90-300-255042024-04-24
Xtant Medical, Inc.
nanOss 3D Advanced Bone Graft Substitute 90-300-2510082024-04-24
Xtant Medical, Inc.
nanOss 3D Advanced Bone Graft Substitute 90-300-2510042024-04-24
Xtant Medical, Inc.
nanOss Loaded Advanced Bone Graft Substitute Kit 90-200-10K2024-04-24
Xtant Medical, Inc.
nanOss Loaded Advanced Bone Graft Substitute Kit 90-200-05K2024-04-24
Xtant Medical, Inc.
nanOss Advanced Bone Graft Substitute 90-100-202024-04-24
Xtant Medical, Inc.
nanOss Advanced Bone Graft Substitute 90-100-102024-04-24
Xtant Medical, Inc.
nanOss Advanced Bone Graft Substitute 90-100-052024-04-24
Xtant Medical, Inc.
nanOss Advanced Bone Graft Substitute 90-100-022024-04-24
Xtant Medical, Inc.
nanOss Advanced Bone Graft Substitute 90-100-012024-04-24
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect, OsteoSelect Plus2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect, OsteoSelect Plus2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
OsteoSelect2018-12-31
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
X-spine Cortical Bone Screw2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
InTice-C Porous Ti Cervical Interbody System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
IRIX-A Lumbar Integrated Fusion System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Butrex Lumbar Buttress Plating System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
X-spine Pedicle Screw System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
X-spine Pedicle Screw System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Silex Sacroiliac Joint Fusion System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Anterior Compact Plate (ACP) System2018-06-18
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Irix-C Cervical Integrated Fusion System2017-11-28
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix-C Cervical Interbody Spacer2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Spider Cervical Plating System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix Lumbar Spinal Implant System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Certex Spinal Fixation System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Certex Spinal Fixation System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Certex OCT Spinal Implant System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix Lumbar Spinal Implant System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fortex Pedicle Screw System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fortex Pedicle Screw System2017-11-27
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Xsert Expandable Lumbar Fusion System2016-12-08
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Xspan Laminoplasty Fixation System2016-03-15
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Aranax Anterior Cervical Plating System2015-09-09
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Forceps2015-09-09
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Rongeur2015-08-24
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Scalpel Handle2015-08-24
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Biopsy Needle2015-08-19
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Irix-A Lumbar Integrated Fusion System2015-04-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Cutting Instrument2015-01-28
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Surgical Tray2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Caliper2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Drill Brace2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Screwdriver2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Bender2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Wire cutter2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Rod cutter2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Mallet2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Tamp2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fork2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Clamp2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Wrench2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Handle2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Probe2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Bone Tap2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Trial2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Template2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Sizer2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Compressor2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Awl2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Extractor2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Distractor2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Inserter2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Impactor2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Drill Bit2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Rasp2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Broach2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Depth Gauge2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Curette2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Elevator2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Pliers2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Osteotome2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Pin Driver2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Dissector2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Pin2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Needle Guide2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Guide Needle2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Retractor2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Tissue Shield2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Instrument Guide2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Knife2014-04-17
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Axle-X Interspinous Fusion System2014-01-11
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Adaptor, 1/4" Square/Jacobs Chuck2013-12-09
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Irix-C Cervical Integrated Fusion System2013-12-06
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Zyfix Spinal Facet Screw System2013-12-06
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Orthopedic Manual Surgical Instrument2013-12-06
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Silex Sacroiliac Joint Fusion System2013-04-10
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Certex Spinal Implant System2012-11-30
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Certex Spinal Implant System2012-11-30
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Axle PEEK Interspinous Fusion System2011-12-21
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix PC Spinal Implant System2011-12-21
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix PC Spinal Implant System2011-12-21
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Axle Interspinous Fusion System2011-01-10
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fixcet Spinal Facet Screw System2011-01-10
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
ACP4 Spinal Implant System2011-01-10
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Xpress Pedicle Screw System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fortex Pedicle Screw System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Xpress Pedicle Screw System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Fortex Pedicle Screw System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix Spinal Implant System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Calix Spinal Implant System2009-12-03
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Butrex Buttress Plating System2009-01-26
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
X90 Pedicle Screw System2009-01-26
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Capless Pedicle Screw System2009-01-26
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
X90 Pedicle Screw System2009-01-26
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Capless Pedicle Screw System2009-01-26
X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]
Spider Cervical Plating System2009-01-26

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