FDA 510(k), K171595, M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

FDA 510(k), K171595, M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

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510(K) Number: K171595
Device Name: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Manufacturer: Stefano Baj
Device Classification Name: Sacroiliac Joint Fixation
Regulation Number: OUR
Classification Product Code: KXA
Date Received: 05/31/2017
Decision Date: 08/02/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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