FDA 510(k) Application Details - K111077

Device Classification Name

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510(K) Number K111077
Device Name ORTHOSORB RESORBABLE PINS
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581 US
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Contact SUZANA OTANO
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Regulation Number

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Classification Product Code OVZ
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Date Received 04/18/2011
Decision Date 07/12/2011
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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