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FDA 510(k)

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

K-Number: K203671 · 2021-01-13

ApplicantMedacta International S.A.
Decision Date2021-01-13
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-01-13 under approval number K203671. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System?

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is a medical device that received FDA 510(k) clearance on 2021-01-13. It is manufactured by Medacta International S.A.. The 510(k) number is K203671.

When was M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System approved by the FDA?

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System received FDA 510(k) clearance on 2021-01-13, under approval number K203671.

What company makes M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System?

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is manufactured by Medacta International S.A..

What is the FDA product code for M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System?

The FDA product code for M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07193407 INOPASE - Performance and Safety Study of a Personalised SNM System RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT06511141 Sacral Neuromodulation for Male Overactive Bladder (MOAB) RECRUITING

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Medacta International S.A.

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Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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