iFuse Bedrock Granite Implant System
K-Number: K253094 · 2025-10-09
ApplicantSI-BONE, Inc.
Decision Date2025-10-09
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
iFuse Bedrock Granite Implant System is a medical device manufactured by SI-BONE, Inc.. It received FDA 510(k) clearance on 2025-10-09 under approval number K253094. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iFuse Bedrock Granite Implant System?
iFuse Bedrock Granite Implant System is a medical device that received FDA 510(k) clearance on 2025-10-09. It is manufactured by SI-BONE, Inc.. The 510(k) number is K253094.
When was iFuse Bedrock Granite Implant System approved by the FDA?
iFuse Bedrock Granite Implant System received FDA 510(k) clearance on 2025-10-09, under approval number K253094.
What company makes iFuse Bedrock Granite Implant System?
iFuse Bedrock Granite Implant System is manufactured by SI-BONE, Inc..
What is the FDA product code for iFuse Bedrock Granite Implant System?
The FDA product code for iFuse Bedrock Granite Implant System is OUR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.