FDA 510(k) Application Details - K051296

Device Classification Name

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510(K) Number K051296
Device Name SIJF CANNULATED SCREW SYSTEM
Applicant DEPUY SPINE, INC.
325 PARAMOUNT DRIVE
RAYNHAM, MA 02780 US
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Contact SHARON STAROWICZ
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Regulation Number

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Classification Product Code OUR
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Date Received 05/18/2005
Decision Date 08/26/2005
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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