K-numberK222971
Device nameULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
ApplicantSmith & Nephew, Inc.
Product codeMBI
Device classClass II
Decision dateFeb 17, 2023
DecisionSubstantially Equivalent
Regulation888.3040
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