FDA 510(k) Application Details - K234031

Device Classification Name Plate, Fixation, Bone

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510(K) Number K234031
Device Name Plate, Fixation, Bone
Applicant Medline Industires, LP
Three Lakes Drive
Northfield, IL 60093 US
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Contact Jennifer Mason
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 12/20/2023
Decision Date 01/18/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K234031


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