FDA 510(k) Application Details - K961522

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K961522
Device Name Pin, Fixation, Smooth
Applicant SYNVASIVE TECHNOLOGY, INC.
4925 ROBERT J. MATHEWS PKWY.
EL DORADO HILLS, CA 95762 US
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Contact MICHAEL G FISHER
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 04/22/1996
Decision Date 09/23/1996
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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