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MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC a — Medacta International S.A. (510(k) K2

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC a — Medacta International S.A. (510(k) K2 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC a; Applican

Device nameMySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC a
ApplicantMedacta International S.A.
Clearance track510(k)
Submission numberK203673
DecisionSubstantially Equivalent
Decision date2021-04-06
Date received2020-12-16
Product codePQC
Device class2
Medical specialtyOrthopedic
Applicant locationCH
SourceopenFDA device

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