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.

USANASDAQSIBNDUNS 830127168
FDA Registration(s)
Registration Number3007700286
FEI Number3007700286
NameSI-BONE, INC.
Owner & OperatorSI-BONE, Inc.
Contact Address471 El Camino Real (effective April 1, 2 Suite 101
Santa Clara CA 95050 US
Official Correspondent
  • Susan Noriega
  • x-669-2062442-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address471 El Camino Real, Suite 101
Santa Clara, CA 95050 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SI-BONE, Inc.
IFuse-TORQ® Implant System2022-06-10
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
Si-Bone Inc.
iFuse Granite Implant System 2022-06-08
SI-BONE, Inc.
IFuse Bedrock Granite™ Implant System2022-05-26
SI-BONE, Inc.
IFuse-TORQ™ Implant System2021-02-25
Si-Bone, Inc
SI-BONE IFuse Implant System®2020-03-31
SI-BONE, Inc.
IFuse Implant System®2019-04-03
SI-BONE, Inc.
IFuse Implant System®2018-11-27
SI-BONE, INC.
iFuse Implant System2018-10-03
SI-BONE, INC.
iFuse Navigation2017-11-03
SI-BONE, Inc.
IFuse Implant System- IFuse Navigation2017-10-31
SI-BONE, INC.
IFuse Implant System® - IFuse-3D Implant2017-03-10
SI-BONE, INC.
SI-BONE Neuromonitoring Kit2016-10-19
SI-BONE, INC.
Neuromonitoring Kit2016-10-18
SI-BONE, INC.
IFUSE Implant System2016-06-03
SI-BONE, INC.
IFuse Implant System(R)2016-03-01
SI-BONE, INC.
IFuse Implant System2015-10-29
SI-BONE, Inc.
IFuse Implant System2015-07-22
SI-BONE, Inc.
SI-BONE IFuse Implant System2015-04-17
SI-BONE, INC.
IFUSE IMPLANT SYSTEM2014-07-23
SI-BONE, INC.
IFUSE IMPLANT SYSTEM2013-10-16
SI-BONE, INC.
IFUSE IMPLANT SYSTEM2013-04-01
SI-BONE, INC.
IFUSE IMPLANT SYSTEM2012-10-12
SI-BONE, INC.
IFUSE IMPLANT SYSTEM2011-04-21
SI-BONE, INC.
XL Cannulated Drill Bit, 7.0mm2011-01-25
SI-BONE, INC.
XL Cannulated Drill Bit, 4.0mm2011-01-25
SI-BONE, INC.
Cannulated Drill Bit, 7.0mm2011-01-25
SI-BONE, INC.
Cannulated Drill Bit, 4.0mm2011-01-25
SI-BONE, INC.
Slotted Mallet2011-01-25
SI-BONE, INC.
Slap Hammer Combo2011-01-25
SI-BONE, INC.
XL Tray System2011-01-20
SI-BONE, INC.
XL Pin Sleeve 7.0mm2011-01-20
SI-BONE, INC.
XL Pin Sleeve 4.0mm2011-01-20
SI-BONE, INC.
XL Guide Pin 3.2mm2011-01-20
SI-BONE, INC.
XL Guide Pin 2.0mm2011-01-20
SI-BONE, INC.
XL Fixed Parallel Pin Guide2011-01-20
SI-BONE, INC.
XL Drill Sleeve, 7.0mm2011-01-20
SI-BONE, INC.
XL Drill Sleeve 4.0mm2011-01-20
SI-BONE, INC.
XL Blunt Pin 3.2mm2011-01-20
SI-BONE, INC.
XL Blunt Pin 2.0mm2011-01-20
SI-BONE, INC.
XL Adjustable Parallel Pin Guide2011-01-20
SI-BONE, INC.
Variable Parallel Pin Guide2011-01-20
SI-BONE, INC.
Variable Parallel Pin Guide, Molded2011-01-20
SI-BONE, INC.
Steinmann Pin, 3.0mm2011-01-20
SI-BONE, INC.
Steinmann Pin, 1.8mm2011-01-20
SI-BONE, INC.
Slap Hammer, Combo2011-01-20
SI-BONE, INC.
SI-BONE iFuse Tray2011-01-20
SI-BONE, INC.
S-Pin, Thrd, Ball End, 3.0mm2011-01-20
SI-BONE, INC.
S-Pin, Thrd, Ball End 1.8mm2011-01-20
SI-BONE, INC.
Pin, Extension, 1.8mm2011-01-20
SI-BONE, INC.
Pin, Extension 3.0mm2011-01-20
SI-BONE, INC.
Pin Sleeve2011-01-20
SI-BONE, INC.
Pin Sleeve, 7.0mm2011-01-20
SI-BONE, INC.
Pin Sleeve, 4.0 mm2011-01-20
SI-BONE, INC.
PPG Fixed Distance Plastic Head 15mm Press Fit2011-01-20
SI-BONE, INC.
Instrument Tray2011-01-20
SI-BONE, INC.
Guide Pin, 3.2mm2011-01-20
SI-BONE, INC.
Guide Pin, 2.0 mm2011-01-20
SI-BONE, INC.
Guide Pin 3.2mm2011-01-20
SI-BONE, INC.
Guide Pin 2.0mm2011-01-20
SI-BONE, INC.
Fixed Parallel Pin Guide2011-01-20
SI-BONE, INC.
Exchange Pin, 3.2 mm2011-01-20
SI-BONE, INC.
Exchange Pin, 2.0 mm2011-01-20
SI-BONE, INC.
Exchange Pin 3.2mm2011-01-20
SI-BONE, INC.
Exchange Pin 2.0mm2011-01-20
SI-BONE, INC.
Drill Sleeve Assembly2011-01-20
SI-BONE, INC.
Drill Sleeve Assembly, 4.0mm2011-01-20
SI-BONE, INC.
Blunt Pin, 3.2mm2011-01-20
SI-BONE, INC.
Blunt Pin, 2.0mm2011-01-20
SI-BONE, INC.
Blunt Pin 3.2mm2011-01-20
SI-BONE, INC.
Blunt Pin 2.0mm2011-01-20
SI-BONE, INC.
Adjustable Parallel Pin Guide2011-01-20
SI-BONE, INC.
Adjustable Broach Stop2011-01-20
SI-BONE, INC.
Adapter, Stealth Pin Guide2011-01-20
SI-BONE, INC.
MODIFICATION TO SI JOINT FUSION SYSTEM2009-09-04
SI-BONE, INC.
SI JOINT FUSION SYSTEM2008-11-26

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