FDA.report

SI-BONE, INC.

Matched from indexed company URL: SI-BONE INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30077002863007700286SI-BONE, INC.1N2026-01-01471 El Camino Real, Suite 101 Santa Clara CA US 95050
30219480573021948057SI-BONE, INC.1N2026-01-012380 Owen St. Santa Clara CA US 95054

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00810055524754iGPS 4.3mm Drill Bit - 503042855-884-3873info@si-bone.com
00810055524761iGPS 7.0mm Drill Bit - 502137-0700855-884-3873info@si-bone.com
00810055525768iFuse INTRA Ti Implant - 6030K855-884-3873info@si-bone.com
00869397000013XL Instrument Set - 400062855-884-3873info@si-bone.com
00869397000020Radiolucent Instrument Set - 400091855-884-3873info@si-bone.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3026941263128982K253488iFuse INTRA Ti™ Implant SystemOUR2026-02-11
1037221263128982K253488iFuse INTRA Ti™ Implant SystemOUR2026-02-11
1037221326477011K253094iFuse Bedrock Granite Implant SystemOUR2025-10-09
3026941326477011K253094iFuse Bedrock Granite Implant SystemOUR2025-10-09
3026941614460070K251780iGPS Navigation InstrumentsOLO2025-09-15
1037221614460070K251780iGPS Navigation InstrumentsOLO2025-09-15
3026941047486582K241574iFuse TORQ® Implant SystemOUR2024-07-02
1037221047486582K241574iFuse TORQ® Implant SystemOUR2024-07-02
3026941797153860K241504iFuse TORQ TNT™ Implant SystemOUR2024-08-19
1037221797153860K241504iFuse TORQ TNT™ Implant SystemOUR2024-08-19
1037222072962170K233508iFuse Bedrock Granite® Implant SystemOUR2024-01-26
3026942072962170K233508iFuse Bedrock Granite® Implant SystemOUR2024-01-26
1037221147859972K232800Navigation Tracking InstrumentsOLO2024-02-23
3026941147859972K232800Navigation Tracking InstrumentsOLO2024-02-23
3026941862076135K231689iFuse TORQ® Implant SystemOUR2023-06-30
1037221862076135K231689iFuse TORQ® Implant SystemOUR2023-06-30
1037221481813921K222774iFuse Bedrock Granite® Implant SystemOUR2022-12-22
3026941481813921K222774iFuse Bedrock Granite® Implant SystemOUR2022-12-22
1037221594733664K222605iFuse TORQ® Implant SystemOUR2022-09-29
3026941594733664K222605iFuse TORQ® Implant SystemOUR2022-09-29
1037221068145376K220195iFuse Bedrock Granite™ Implant SystemOUR2022-05-26
3026941068145376K220195iFuse Bedrock Granite™ Implant SystemOUR2022-05-26
3026941539778911K213667iFuse-TORQ® Implant SystemOUR2022-06-10
1037221539778911K213667iFuse-TORQ® Implant SystemOUR2022-06-10
1037221960049642K203247iFuse-TORQ™ Implant SystemOUR2021-02-25
3026941960049642K203247iFuse-TORQ™ Implant SystemOUR2021-02-25
3026941570647803K203110iFuse Implant System - iFuse NavigationOLO2020-11-09
1037221570647803K203110iFuse Implant System - iFuse NavigationOLO2020-11-09
3026941841037193K193524SI-BONE iFuse Implant System®OUR2020-03-31
1037221841037193K193524SI-BONE iFuse Implant System®OUR2020-03-31
3026941667023626K190230iFuse Implant System®OUR2019-04-03
1037221667023626K190230iFuse Implant System®OUR2019-04-03
3026941568518597K182983iFuse Implant System®OUR2018-11-27
1037221568518597K182983iFuse Implant System®OUR2018-11-27
3026941469916157K172268iFuse Implant System- iFuse NavigationOLO2017-10-31
1037221469916157K172268iFuse Implant System- iFuse NavigationOLO2017-10-31
3026941494339725K162733iFuse Implant System® - iFuse-3D implantOUR2017-03-10
1037221494339725K162733iFuse Implant System® - iFuse-3D implantOUR2017-03-10
3026941088159917K161893Neuromonitoring KitPDQ2016-10-18
1037221088159917K161893Neuromonitoring KitPDQ2016-10-18
3026941266932962K160652iFUSE Implant SystemOUR2016-06-03
1037221266932962K160652iFUSE Implant SystemOUR2016-06-03
3026941402129602K152681iFuse Implant System(R)OUR2016-03-01
1037221402129602K152681iFuse Implant System(R)OUR2016-03-01
3026941919438989K151718iFuse Implant SystemOUR2015-10-29
1037221919438989K151718iFuse Implant SystemOUR2015-10-29
3026941500220304K150875iFuse Implant SystemOUR2015-07-22
1037221500220304K150875iFuse Implant SystemOUR2015-07-22
3026941197957534K150714SI-BONE iFuse Implant SystemOUR2015-04-17
1037221197957534K150714SI-BONE iFuse Implant SystemOUR2015-04-17
1037221383832950K141049IFUSE IMPLANT SYSTEMOUR2014-07-23
3026941383832950K141049IFUSE IMPLANT SYSTEMOUR2014-07-23
3026941501297849K131405IFUSE IMPLANT SYSTEMOUR2013-10-16
1037221412419419K123850IFUSE IMPLANT SYSTEMOUR2013-04-01
3026941412419419K123850IFUSE IMPLANT SYSTEMOUR2013-04-01
3026941153235134K122074IFUSE IMPLANT SYSTEMOUR2012-10-12
1037221153235134K122074IFUSE IMPLANT SYSTEMOUR2012-10-12
3026941327745929K110838IFUSE IMPLANT SYSTEMOUR2011-04-21
3026941163822582K092375MODIFICATION TO SI JOINT FUSION SYSTEMOUR2009-09-04
3026941032720694K080398SI JOINT FUSION SYSTEMOUR2008-11-26
1037221091554776
3026941091554776
3026941350412226
1037221350412226
3026941413016293
3026941549589440
1037221549589440
3026941748761216
1037221748761216
3026941987033092

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
OUR502026-02-11
OLO82025-09-15
PDQ22016-10-18

PMN

GUDID

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