FDA 510(k) Application Details - K040765

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K040765
Device Name Pin, Fixation, Threaded
Applicant SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact LISA M BOYLE
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 03/25/2004
Decision Date 04/12/2004
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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