FDA 510(k) Application Details - K062250

Device Classification Name

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510(K) Number K062250
Device Name DELTA XTEND REVERSE SHOULDER SYSTEM
Applicant DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
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Contact NATALIE S HECK
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Regulation Number

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Classification Product Code PHX
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Date Received 08/02/2006
Decision Date 02/02/2007
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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