iFuse Bedrock Granite® Implant System
K-Number: K222774 · 2022-12-22
ApplicantSI-BONE, Inc.
Decision Date2022-12-22
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 2022-12-22 under approval number K222774. 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 2022-12-22. It is manufactured by SI-BONE, Inc.. The 510(k) number is K222774.
When was iFuse Bedrock Granite® Implant System approved by the FDA?
iFuse Bedrock Granite® Implant System received FDA 510(k) clearance on 2022-12-22, under approval number K222774.
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.