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FDA 510(k), K193083, M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
FDA 510(k), K193083, M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
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510(K) Number: K193083
Device Name: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
Manufacturer: Stefano Baj
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: 11/05/2019
Date Received: 12/03/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
Manufacturer: Stefano Baj
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: 11/05/2019
Date Received: 12/03/2019
Decision Date: Substantially Equivalent (SESE)
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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