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FDA 510(k), K131405, IFUSE IMPLANT SYSTEM
FDA 510(k), K131405, IFUSE IMPLANT SYSTEM
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510(K) Number: K131405
Device Name: IFUSE IMPLANT SYSTEM
Manufacturer: SI-BONE, INC.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 05/15/2013
Decision Date: 10/16/2013
Regulation Medical Specialty: Orthopedic
Device Name: IFUSE IMPLANT SYSTEM
Manufacturer: SI-BONE, INC.
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 05/15/2013
Decision Date: 10/16/2013
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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