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FDA 510(k), K220195, iFuse Bedrock Granite™ Implant System
FDA 510(k), K220195, iFuse Bedrock Granite™ Implant System
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$149.00 USD
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510(K) Number: K220195
Device Name: iFuse Bedrock Granite™ Implant System
Manufacturer: SI-BONE, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 01/24/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Orthopedic
Device Name: iFuse Bedrock Granite™ Implant System
Manufacturer: SI-BONE, Inc.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 01/24/2022
Decision Date: 05/26/2022
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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