FDA Device Entity Profile: SI-BONE, Inc.

Known Identifiers & Locations

FEI Numbers 3007700286, 3021948057

Owner Operator Numbers 10029402

Locations Covered Santa Clara, CA, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3007700286	SI-BONE, INC.	Santa Clara, CA, US	Complaint File Establishment per 21 CFR 820.198	View Details
3021948057	SI-BONE, INC.	Santa Clara, CA, US	Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K213667	iFuse-TORQ® Implant System	2022-06-10	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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