Medical Device Manufacturer · US , Santa Clara , CA

SI-BONE, Inc.

32 submissions · 32 cleared · Since 2008
32
Total
32
Cleared
0
Denied

SI-BONE, Inc. — FDA 510(k) Submissions

SI-BONE, Inc. has submitted 32 FDA 510(k) premarket notifications since 2008, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sacroiliac Joint Fixation, Orthopedic Stereotaxic Instrument, Neurosurgical Nerve Locator . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
iFuse INTRA Ti? Implant System
K253488 · OUR Sacroiliac Joint Fixation · Orthopedic
Feb 2026 110d
iFuse Bedrock Granite Implant System
K253094 · OUR Sacroiliac Joint Fixation · Orthopedic
Oct 2025 16d
iGPS Navigation Instruments
K251780 · OLO Orthopedic Stereotaxic... · Orthopedic
Sep 2025 97d
iFuse TORQ TNT? Implant System
K241504 · OUR Sacroiliac Joint Fixation · Orthopedic
Aug 2024 83d
iFuse TORQ? Implant System
K241574 · OUR Sacroiliac Joint Fixation · Orthopedic
Jul 2024 29d
Navigation Tracking Instruments
K232800 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2024 164d
iFuse Bedrock Granite? Implant System
K233508 · OUR Sacroiliac Joint Fixation · Orthopedic
Jan 2024 87d
iFuse TORQ? Implant System
K231689 · OUR Sacroiliac Joint Fixation · Orthopedic
Jun 2023 21d
iFuse Bedrock Granite? Implant System
K222774 · OUR Sacroiliac Joint Fixation · Orthopedic
Dec 2022 99d
iFuse TORQ? Implant System
K222605 · OUR Sacroiliac Joint Fixation · Orthopedic
Sep 2022 31d
iFuse-TORQ? Implant System
K213667 · OUR Sacroiliac Joint Fixation · Orthopedic
Jun 2022 200d
iFuse Bedrock Granite? Implant System
K220195 · OUR Sacroiliac Joint Fixation · Orthopedic
May 2022 122d
iFuse-TORQ? Implant System
K203247 · OUR Sacroiliac Joint Fixation · Orthopedic
Feb 2021 113d
iFuse Implant System - iFuse Navigation
K203110 · OLO Orthopedic Stereotaxic... · Orthopedic
Nov 2020 25d
SI-BONE iFuse Implant System?
K193524 · OUR Sacroiliac Joint Fixation · Orthopedic
Mar 2020 103d
iFuse Implant System?
K190230 · OUR Sacroiliac Joint Fixation · Orthopedic
Apr 2019 56d
iFuse Implant System?
K182983 · OUR Sacroiliac Joint Fixation · Orthopedic
Nov 2018 29d
iFuse Implant System- iFuse Navigation
K172268 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2017 96d
iFuse Implant System? - iFuse-3D implant
K162733 · OUR Sacroiliac Joint Fixation · Orthopedic
Mar 2017 162d
Neuromonitoring Kit
K161893 · PDQ Neurosurgical Nerve Locator · Neurology
Oct 2016 99d
iFUSE Implant System
K160652 · OUR Sacroiliac Joint Fixation · Orthopedic
Jun 2016 87d
iFuse Implant System(R)
K152681 · OUR Sacroiliac Joint Fixation · Orthopedic
Mar 2016 165d
iFuse Implant System
K151718 · OUR Sacroiliac Joint Fixation · Orthopedic
Oct 2015 126d
iFuse Implant System
K150875 · OUR Sacroiliac Joint Fixation · Orthopedic
Jul 2015 112d
SI-BONE iFuse Implant System
K150714 · OUR Sacroiliac Joint Fixation · Orthopedic
Apr 2015 29d
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