FDA 510(k) Application Details - K131552

Device Classification Name Plate, Fixation, Bone

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510(K) Number K131552
Device Name Plate, Fixation, Bone
Applicant CONVENTUS ORTHOPAEDICS
10200 73RD AVENUE NORTH
STE 122
MAPLE GROVE, MN 55369 US
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Contact KENT LIND
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Regulation Number 888.3030

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Classification Product Code HRS
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Date Received 05/30/2013
Decision Date 02/12/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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