FDA 510(k) Application Details - K141737

Device Classification Name Nail, Fixation, Bone

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510(K) Number K141737
Device Name Nail, Fixation, Bone
Applicant CONVENTUS ORTHOPAEDICS, INC.
10200 73RD AVE. N, 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 JDS
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Date Received 06/27/2014
Decision Date 04/08/2015
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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