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FDA 510(k), K190230, iFuse Implant System®
FDA 510(k), K190230, iFuse Implant System®
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510(K) Number: K190230
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: 02/06/2019
Decision Date: 04/03/2019
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: 02/06/2019
Decision Date: 04/03/2019
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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