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
PMN K213667 SI-BONE, Inc.	IFuse-TORQ® Implant System	2022-06-10
GUDID 00810055521807 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521791 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521784 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521777 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521760 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521753 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521746 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521739 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521722 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521715 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521708 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521692 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521685 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521678 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521661 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521654 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521647 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521630 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521623 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521616 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521609 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521593 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521586 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521579 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521562 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521555 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521548 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521531 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521524 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521517 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521500 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521494 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521487 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521470 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521463 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521456 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521449 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521432 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521425 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521418 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521401 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521395 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521388 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521371 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521364 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521357 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521340 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521333 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521326 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521319 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521302 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521296 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521289 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521272 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521265 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521258 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521241 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521234 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521227 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521210 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521203 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521173 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521166 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521142 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521135 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521098 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521081 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521074 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521067 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521050 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521043 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521036 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521029 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521012 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055521005 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520992 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520985 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520978 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520961 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520954 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520947 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520930 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520923 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520916 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520909 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520893 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520886 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520879 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520862 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520855 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520848 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520831 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520824 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520800 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520794 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520787 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520770 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520763 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520756 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
GUDID 00810055520749 Si-Bone Inc.	iFuse Granite Implant System	2022-06-08
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