SI-BONE, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
SI-BONE, Inc. - FDA 510(k) Cleared Devices
Recent clearances: iFuse INTRA Ti™ Implant System, iFuse Bedrock Granite Implant System, iGPS Navigation Instruments
32
Total
32
Cleared
0
Denied
SI-BONE, Inc. has 32 FDA 510(k) cleared orthopedic devices. Based in Santa Clara, US.
Latest FDA clearance: Feb 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Domecus Consulting Services, LLC as regulatory consultant. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - SI-BONE, Inc.
32 devices
Cleared
Feb 11, 2026
iFuse INTRA Ti™ Implant System
Orthopedic
110d
Cleared
Oct 09, 2025
iFuse Bedrock Granite Implant System
Orthopedic
16d
Cleared
Sep 15, 2025
iGPS Navigation Instruments
Orthopedic
97d
Cleared
Aug 19, 2024
iFuse TORQ TNT™ Implant System
Orthopedic
83d
Cleared
Jul 02, 2024
iFuse TORQ® Implant System
Orthopedic
29d
Cleared
Feb 23, 2024
Navigation Tracking Instruments
Orthopedic
164d
Cleared
Jan 26, 2024
iFuse Bedrock Granite® Implant System
Orthopedic
87d
Cleared
Jun 30, 2023
iFuse TORQ® Implant System
Orthopedic
21d
Cleared
Dec 22, 2022
iFuse Bedrock Granite® Implant System
Orthopedic
99d
Cleared
Sep 29, 2022
iFuse TORQ® Implant System
Orthopedic
31d
Cleared
Jun 10, 2022
iFuse-TORQ® Implant System
Orthopedic
200d
Cleared
May 26, 2022
iFuse Bedrock Granite™ Implant System
Orthopedic
122d