X Spine Systems Bacterin I N T

FDA Filings

This page includes the latest FDA filings for X Spine Systems Bacterin I N T. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005031160
• FEI Number: 3005031160
• Name: X-SPINE SYSTEMS/Bacterin International
• Owner & Operator: Xtant Medical Inc.
• Contact Address: 664 Cruiser Lane ; Belgrade MT 59714 US
• Official Correspondent:
  • Casey Ming
  • x-406-3880480-1128
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 664 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	Device	Date
PMN K150621 | MQV X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect, OsteoSelect Plus	2018-12-31
PMN K150621 | MBP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect, OsteoSelect Plus	2018-12-31
PMN K130498 | MQV X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect	2018-12-31
PMN K130498 | MBP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect	2018-12-31
PMN K091321 | MQV X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect	2018-12-31
PMN K091321 | MBP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	OsteoSelect	2018-12-31
PMN K180153 | NKB X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	X-spine Cortical Bone Screw	2018-06-18
PMN K173832 | ODP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	InTice-C Porous Ti Cervical Interbody System	2018-06-18
PMN K171567 | OVD X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	IRIX-A Lumbar Integrated Fusion System	2018-06-18
PMN K170530 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Butrex Lumbar Buttress Plating System	2018-06-18
PMN K152132 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	X-spine Pedicle Screw System	2018-06-18
PMN K152132 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	X-spine Pedicle Screw System	2018-06-18
PMN K140079 | OUR X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Silex Sacroiliac Joint Fusion System	2018-06-18
PMN K041469 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Anterior Compact Plate (ACP) System	2018-06-18
PMN K162944 | OVE X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Irix-C Cervical Integrated Fusion System	2017-11-28
PMN K171075 | ODP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix-C Cervical Interbody Spacer	2017-11-27
PMN K170224 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Spider Cervical Plating System	2017-11-27
PMN K170119 | MAX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix Lumbar Spinal Implant System	2017-11-27
PMN K160428 | NKG X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Certex Spinal Fixation System	2017-11-27
PMN K160428 | KWP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Certex Spinal Fixation System	2017-11-27
PMN K133094 | KWP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Certex OCT Spinal Implant System	2017-11-27
PMN K131350 | MAX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix Lumbar Spinal Implant System	2017-11-27
PMN K120832 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fortex Pedicle Screw System	2017-11-27
PMN K120832 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fortex Pedicle Screw System	2017-11-27
PMN K160959 | MAX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Xsert Expandable Lumbar Fusion System	2016-12-08
PMN K160114 | NQW X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Xspan Laminoplasty Fixation System	2016-03-15
PMN K150834 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Aranax Anterior Cervical Plating System	2015-09-09
HTD X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Forceps	2015-09-09
HTX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Rongeur	2015-08-24
GDZ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Scalpel Handle	2015-08-24
MJG X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Biopsy Needle	2015-08-19
PMN K133947 | OVD X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Irix-A Lumbar Integrated Fusion System	2015-04-03
HTZ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Cutting Instrument	2015-01-28
LRP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Surgical Tray	2014-04-17
KTZ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Caliper	2014-04-17
HXY X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Drill Brace	2014-04-17
HXX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Screwdriver	2014-04-17
HXW X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Bender	2014-04-17
HXP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Wire cutter	2014-04-17
HXP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Rod cutter	2014-04-17
HXL X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Mallet	2014-04-17
HXG X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Tamp	2014-04-17
HXE X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fork	2014-04-17
HXD X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Clamp	2014-04-17
HXC X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Wrench	2014-04-17
HXC X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Handle	2014-04-17
HXB X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Probe	2014-04-17
HWX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Bone Tap	2014-04-17
HWT X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Trial	2014-04-17
HWT X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Template	2014-04-17
HWT X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Sizer	2014-04-17
HWN X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Compressor	2014-04-17
HWJ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Awl	2014-04-17
HWB X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Extractor	2014-04-17
HWB X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Distractor	2014-04-17
HWA X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Inserter	2014-04-17
HWA X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Impactor	2014-04-17
HTW X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Drill Bit	2014-04-17
HTR X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Rasp	2014-04-17
HTQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Broach	2014-04-17
HTJ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Depth Gauge	2014-04-17
HTF X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Curette	2014-04-17
HTE X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Elevator	2014-04-17
HTC X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Pliers	2014-04-17
GFI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Osteotome	2014-04-17
GFC X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Pin Driver	2014-04-17
GDI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Dissector	2014-04-17
GDF X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Pin	2014-04-17
GDF X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Needle Guide	2014-04-17
GDF X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Guide Needle	2014-04-17
GAD X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Retractor	2014-04-17
FZX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Tissue Shield	2014-04-17
FZX X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Instrument Guide	2014-04-17
EMF X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Knife	2014-04-17
PMN K130438 | PEK X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Axle-X Interspinous Fusion System	2014-01-11
HWE X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Adaptor, 1/4" Square/Jacobs Chuck	2013-12-09
PMN K131951 | OVE X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Irix-C Cervical Integrated Fusion System	2013-12-06
PMN K123932 | MRW X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Zyfix Spinal Facet Screw System	2013-12-06
LXH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Orthopedic Manual Surgical Instrument	2013-12-06
PMN K123702 | OUR X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Silex Sacroiliac Joint Fusion System	2013-04-10
PMN K122163 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Certex Spinal Implant System	2012-11-30
PMN K122163 | KWP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Certex Spinal Implant System	2012-11-30
PMN K112592 | KWP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Axle PEEK Interspinous Fusion System	2011-12-21
PMN K112036 | ODP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix PC Spinal Implant System	2011-12-21
PMN K112036 | MQP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix PC Spinal Implant System	2011-12-21
PMN K101471 | KWP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Axle Interspinous Fusion System	2011-01-10
PMN K100154 | MRW X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fixcet Spinal Facet Screw System	2011-01-10
PMN K092360 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	ACP4 Spinal Implant System	2011-01-10
PMN K090224 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Xpress Pedicle Screw System	2009-12-03
PMN K090224 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fortex Pedicle Screw System	2009-12-03
PMN K090224 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Xpress Pedicle Screw System	2009-12-03
PMN K090224 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Fortex Pedicle Screw System	2009-12-03
PMN K083637 | ODP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix Spinal Implant System	2009-12-03
PMN K083637 | MQP X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Calix Spinal Implant System	2009-12-03
PMN K072943 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Butrex Buttress Plating System	2009-01-26
PMN K052847 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	X90 Pedicle Screw System	2009-01-26
PMN K052847 | MNI X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Capless Pedicle Screw System	2009-01-26
PMN K052847 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	X90 Pedicle Screw System	2009-01-26
PMN K052847 | MNH X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Capless Pedicle Screw System	2009-01-26
PMN K052292 | KWQ X-SPINE SYSTEMS/Bacterin International [Xtant Medical Inc.]	Spider Cervical Plating System	2009-01-26