FDA 510(k) Application Details - K060283

Device Classification Name Pin, Fixation, Smooth

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510(K) Number K060283
Device Name Pin, Fixation, Smooth
Applicant BONUTTI RESEARCH, INC.
2600 SOUTH RANEY
P.O. BOX 1367
EFFINGHAM, IL 62401 US
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Contact PATRICK BALSMANN
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Regulation Number 888.3040

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Classification Product Code HTY
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Date Received 02/03/2006
Decision Date 02/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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