FDA.report

510(k) K253094

Device
iFuse Bedrock Granite Implant System
Applicant
SI-BONE, Inc.
510(k) number
K253094
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-09
Date received
2025-09-23
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jayasri Prabakaran
Address
471 El Camino Real, Suite 101 Santa Clara CA US 95070 95070

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OUR

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K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical2026-04-08
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K252834Sacroiliac Joint Truss System (SJTS)4Web Medical2026-01-28
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K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25
K250403Catamaran SI Joint Fusion SystemTenon Medical2025-03-21