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FDA 510(k), K080398, SI JOINT FUSION SYSTEM
FDA 510(k), K080398, SI JOINT FUSION SYSTEM
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510(K) Number: K080398
Device Name: SI JOINT FUSION SYSTEM
Manufacturer: SI-BONE, INC.
Device Classification Name: sacroiliac joint fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 02/13/2008
Decision Date: 11/26/2008
Regulation Medical Specialty: Orthopedic
Device Name: SI JOINT FUSION SYSTEM
Manufacturer: SI-BONE, INC.
Device Classification Name: sacroiliac joint fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 02/13/2008
Decision Date: 11/26/2008
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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