Si Bone Inc

FDA Filings

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

USA

NASDAQ

SIBN

DUNS 830127168

FDA Registration(s)

• Registration Number: 3007700286
• FEI Number: 3007700286
• Name: SI-BONE, INC.
• Owner & Operator: SI-BONE, Inc.
• Contact Address: 471 El Camino Real (effective April 1, 2 Suite 101; Santa Clara CA 95050 US
• Official Correspondent:
  • Susan Noriega
  • x-669-2062442-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 471 El Camino Real, Suite 101 ; Santa Clara, CA 95050 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00810055524716 Si-Bone Inc.	iFuse TORQ TNT Navigation Instrument Tray	2024-10-03
GUDID 00810055524709 Si-Bone Inc.	iFuse TORQ TNT Instrument Tray	2024-10-03
GUDID 00810055524440 Si-Bone Inc.	iFuse TORQ TNT Navigation Instrument Set	2024-09-25
GUDID 00810055524433 Si-Bone Inc.	iFuse TORQ TNT Instrument Set	2024-09-25
GUDID 00810055524426 Si-Bone Inc.	8.7 mm X 170 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524419 Si-Bone Inc.	8.7 mm X 165 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524402 Si-Bone Inc.	8.7 mm X 160 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524396 Si-Bone Inc.	8.7 mm X 155 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524389 Si-Bone Inc.	8.7 mm X 150 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524372 Si-Bone Inc.	8.7 mm X 145 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524365 Si-Bone Inc.	8.7 mm X 140 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524358 Si-Bone Inc.	8.7 mm X 135 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524341 Si-Bone Inc.	8.7 mm X 130 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524334 Si-Bone Inc.	8.7 mm X 125 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524327 Si-Bone Inc.	8.7 mm X 120 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524310 Si-Bone Inc.	8.7 mm X 115 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524303 Si-Bone Inc.	8.7 mm X 110 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524297 Si-Bone Inc.	8.7 mm X 105 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524280 Si-Bone Inc.	8.7 mm X 100 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524273 Si-Bone Inc.	8.7 mm X 95 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524266 Si-Bone Inc.	8.7 mm X 90 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524259 Si-Bone Inc.	8.7 mm X 85 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524242 Si-Bone Inc.	8.7 mm X 80 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524235 Si-Bone Inc.	8.7 mm X 75 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524228 Si-Bone Inc.	8.7 mm X 70 mm iFuse TORQ TNT Implant	2024-09-25
GUDID 00810055524211 Si-Bone Inc.	TORQ TNT 21.0mm Washer	2024-09-25
GUDID 00810055524204 Si-Bone Inc.	TORQ TNT 16.0mm Washer	2024-09-25
GUDID 00810055524181 Si-Bone Inc.	Reverse Threaded Navigated Pin, 2.5 mm, TORQ TNT	2024-09-25
GUDID 00810055524174 Si-Bone Inc.	Blunt Pin, 2.5 mm x 330 mm	2024-09-25
GUDID 00810055524136 Si-Bone Inc.	Cleaning Stylet, TORQ TNT	2024-09-25
GUDID 00810055524129 Si-Bone Inc.	Pin Insertion Guide	2024-09-25
GUDID 00810055523771 Si-Bone Inc.	TORQ TNT Navigated Pin Guide	2024-09-25
GUDID 00810055523764 Si-Bone Inc.	TORQ TNT Tap	2024-09-25
GUDID 00810055523757 Si-Bone Inc.	TORQ TNT Fixed Parallel Pin Guide	2024-09-25
GUDID 00810055523733 Si-Bone Inc.	TORQ TNT Drill Sleeve	2024-09-25
GUDID 00810055523726 Si-Bone Inc.	TORQ TNT Soft Tissue Protector	2024-09-25
GUDID 00810055523719 Si-Bone Inc.	TORQ TNT Exchange Tube	2024-09-25
GUDID 00810055523702 Si-Bone Inc.	2.0 mm Pin Repositioner, Even	2024-09-25
GUDID 00810055523696 Si-Bone Inc.	2.5 mm Pin Repositioner, Even	2024-09-25
GUDID 00810055523689 Si-Bone Inc.	2.0 mm Pin Repositioner, Odd	2024-09-25
GUDID 00810055523672 Si-Bone Inc.	2.5 mm Pin Repositioner, Odd	2024-09-25
GUDID 00810055523658 Si-Bone Inc.	TORQ TNT Cannulated Torx Driver	2024-09-25
GUDID 00810055523641 Si-Bone Inc.	TORQ TNT Locking Driver	2024-09-25
GUDID 00810055523627 Si-Bone Inc.	5.5 mm Cannulated Drill Bit, TORQ TNT, 375 mm	2024-09-25
GUDID 00810055523610 Si-Bone Inc.	5.5 mm Cannulated Drill Bit, TORQ TNT, 280 mm	2024-09-25
GUDID 00810055523603 Si-Bone Inc.	4.5 mm Cannulated Drill Bit, TORQ TNT	2024-09-25
GUDID 00810055523597 Si-Bone Inc.	TORQ TNT Dilator	2024-09-25
GUDID 00810055523580 Si-Bone Inc.	TORQ TNT 5.5 mm Navigated Drill Bit	2024-09-25
GUDID 00810055523573 Si-Bone Inc.	Blunt Pin, 2.5 mm x 450 mm	2024-09-25
GUDID 00810055523566 Si-Bone Inc.	Drill Pin, 2.5 mm x 450 mm	2024-09-25
GUDID 00810055523559 Si-Bone Inc.	Reverse Threaded Pin, 2.5 mm x 450 mm	2024-09-25
GUDID 00810055523542 Si-Bone Inc.	Trocar Pin, 2.5 mm x 450 mm	2024-09-25
GUDID 00810055523535 Si-Bone Inc.	Reverse Threaded Pin, 2.5 mm x 330 mm	2024-09-25
GUDID 00810055523528 Si-Bone Inc.	Drill Pin, 2.5 mm x 330 mm	2024-09-25
GUDID 00810055523511 Si-Bone Inc.	Trocar Pin, 2.5 mm x 330 mm	2024-09-25
GUDID 00810055523504 Si-Bone Inc.	Trocar Pin, 2.0 mm x 330 mm, TORQ TNT	2024-09-25
GUDID 00810055523498 Si-Bone Inc.	Trocar Pin, 2.0 mm x 250 mm, TORQ TNT	2024-09-25
GUDID 00810055524457 Si-Bone Inc.	iFuse Granite Implant System-iFuse-Granite+ Instrument Set	2024-05-29
GUDID 00810055524617 Si-Bone Inc.	iFuse INTRA X Instrument Set	2024-05-22
GUDID 00810055524563 Si-Bone Inc.	8-Gauge Bone Access Needle and Tamp	2024-05-22
GUDID 00855369008873 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00855369008866 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00855369008811 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00855369008804 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00855369008798 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00855369008781 Si-Bone Inc.	iFuse Navigation Tracking System	2024-03-25
GUDID 00810055524112 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524105 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524099 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524082 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524075 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524068 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524051 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524044 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524037 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524020 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524013 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055524006 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523993 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523986 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523979 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523962 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523955 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523948 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523931 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523924 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523917 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523900 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523894 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523887 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523870 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523863 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523856 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523849 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523832 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523825 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523818 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523801 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523795 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
GUDID 00810055523788 Si-Bone Inc.	iFuse Bedrock Granite Implant System	2024-03-25
PMN K222605 SI-BONE, Inc.	IFuse TORQ® Implant System	2022-09-29
PMN K213667 SI-BONE, Inc.	IFuse-TORQ® Implant System	2022-06-10
PMN K220195 SI-BONE, Inc.	IFuse Bedrock Granite™ Implant System	2022-05-26
PMN K203247 SI-BONE, Inc.	IFuse-TORQ™ Implant System	2021-02-25
PMN K193524 Si-Bone, Inc	SI-BONE IFuse Implant System®	2020-03-31
PMN K190230 SI-BONE, Inc.	IFuse Implant System®	2019-04-03
PMN K182983 SI-BONE, Inc.	IFuse Implant System®	2018-11-27
PMN K162733 | OUR SI-BONE, INC.	iFuse Implant System	2018-10-03
PMN K172268 | OLO SI-BONE, INC.	iFuse Navigation	2017-11-03
PMN K172268 SI-BONE, Inc.	IFuse Implant System- IFuse Navigation	2017-10-31
PMN K162733 SI-BONE, INC.	IFuse Implant System® - IFuse-3D Implant	2017-03-10
PMN K161893 | PDQ SI-BONE, INC.	SI-BONE Neuromonitoring Kit	2016-10-19
PMN K161893 SI-BONE, INC.	Neuromonitoring Kit	2016-10-18
PMN K160652 SI-BONE, INC.	IFUSE Implant System	2016-06-03
PMN K152681 SI-BONE, INC.	IFuse Implant System(R)	2016-03-01
PMN K151718 SI-BONE, INC.	IFuse Implant System	2015-10-29
PMN K150875 SI-BONE, Inc.	IFuse Implant System	2015-07-22
PMN K150714 SI-BONE, Inc.	SI-BONE IFuse Implant System	2015-04-17
PMN K141049 SI-BONE, INC.	IFUSE IMPLANT SYSTEM	2014-07-23
PMN K131405 SI-BONE, INC.	IFUSE IMPLANT SYSTEM	2013-10-16
PMN K123850 SI-BONE, INC.	IFUSE IMPLANT SYSTEM	2013-04-01
PMN K122074 SI-BONE, INC.	IFUSE IMPLANT SYSTEM	2012-10-12
PMN K110838 SI-BONE, INC.	IFUSE IMPLANT SYSTEM	2011-04-21
HTW SI-BONE, INC.	XL Cannulated Drill Bit, 7.0mm	2011-01-25
HTW SI-BONE, INC.	XL Cannulated Drill Bit, 4.0mm	2011-01-25
HTW SI-BONE, INC.	Cannulated Drill Bit, 7.0mm	2011-01-25
HTW SI-BONE, INC.	Cannulated Drill Bit, 4.0mm	2011-01-25
FZY SI-BONE, INC.	Slotted Mallet	2011-01-25
FZY SI-BONE, INC.	Slap Hammer Combo	2011-01-25
LXH SI-BONE, INC.	XL Tray System	2011-01-20
LXH SI-BONE, INC.	XL Pin Sleeve 7.0mm	2011-01-20
LXH SI-BONE, INC.	XL Pin Sleeve 4.0mm	2011-01-20
LXH SI-BONE, INC.	XL Guide Pin 3.2mm	2011-01-20
LXH SI-BONE, INC.	XL Guide Pin 2.0mm	2011-01-20
LXH SI-BONE, INC.	XL Fixed Parallel Pin Guide	2011-01-20
LXH SI-BONE, INC.	XL Drill Sleeve, 7.0mm	2011-01-20
LXH SI-BONE, INC.	XL Drill Sleeve 4.0mm	2011-01-20
LXH SI-BONE, INC.	XL Blunt Pin 3.2mm	2011-01-20
LXH SI-BONE, INC.	XL Blunt Pin 2.0mm	2011-01-20
LXH SI-BONE, INC.	XL Adjustable Parallel Pin Guide	2011-01-20
LXH SI-BONE, INC.	Variable Parallel Pin Guide	2011-01-20
LXH SI-BONE, INC.	Variable Parallel Pin Guide, Molded	2011-01-20
LXH SI-BONE, INC.	Steinmann Pin, 3.0mm	2011-01-20
LXH SI-BONE, INC.	Steinmann Pin, 1.8mm	2011-01-20
LXH SI-BONE, INC.	Slap Hammer, Combo	2011-01-20
LXH SI-BONE, INC.	SI-BONE iFuse Tray	2011-01-20
LXH SI-BONE, INC.	S-Pin, Thrd, Ball End, 3.0mm	2011-01-20
LXH SI-BONE, INC.	S-Pin, Thrd, Ball End 1.8mm	2011-01-20
LXH SI-BONE, INC.	Pin, Extension, 1.8mm	2011-01-20
LXH SI-BONE, INC.	Pin, Extension 3.0mm	2011-01-20
LXH SI-BONE, INC.	Pin Sleeve	2011-01-20
LXH SI-BONE, INC.	Pin Sleeve, 7.0mm	2011-01-20
LXH SI-BONE, INC.	Pin Sleeve, 4.0 mm	2011-01-20
LXH SI-BONE, INC.	PPG Fixed Distance Plastic Head 15mm Press Fit	2011-01-20
LXH SI-BONE, INC.	Instrument Tray	2011-01-20
LXH SI-BONE, INC.	Guide Pin, 3.2mm	2011-01-20
LXH SI-BONE, INC.	Guide Pin, 2.0 mm	2011-01-20
LXH SI-BONE, INC.	Guide Pin 3.2mm	2011-01-20
LXH SI-BONE, INC.	Guide Pin 2.0mm	2011-01-20
LXH SI-BONE, INC.	Fixed Parallel Pin Guide	2011-01-20
LXH SI-BONE, INC.	Exchange Pin, 3.2 mm	2011-01-20
LXH SI-BONE, INC.	Exchange Pin, 2.0 mm	2011-01-20
LXH SI-BONE, INC.	Exchange Pin 3.2mm	2011-01-20
LXH SI-BONE, INC.	Exchange Pin 2.0mm	2011-01-20
LXH SI-BONE, INC.	Drill Sleeve Assembly	2011-01-20
LXH SI-BONE, INC.	Drill Sleeve Assembly, 4.0mm	2011-01-20
LXH SI-BONE, INC.	Blunt Pin, 3.2mm	2011-01-20
LXH SI-BONE, INC.	Blunt Pin, 2.0mm	2011-01-20
LXH SI-BONE, INC.	Blunt Pin 3.2mm	2011-01-20
LXH SI-BONE, INC.	Blunt Pin 2.0mm	2011-01-20
LXH SI-BONE, INC.	Adjustable Parallel Pin Guide	2011-01-20
LXH SI-BONE, INC.	Adjustable Broach Stop	2011-01-20
LXH SI-BONE, INC.	Adapter, Stealth Pin Guide	2011-01-20
PMN K092375 SI-BONE, INC.	MODIFICATION TO SI JOINT FUSION SYSTEM	2009-09-04
PMN K080398 SI-BONE, INC.	SI JOINT FUSION SYSTEM	2008-11-26

Related Finance Registrations

NCAGE Code	6H4C7	SI-BONE INC.
CAGE Code	6H4C7	SI-BONE INC.
S.A.M. Registration	6H4C7 [830127168]	SI-BONE INC.
S.A.M. Registration	6H4C7 [830127168]	SI-BONE INC.
SEC	0001459839	SI-BONE, Inc. of DELAWARE