FDA 510(k) Application Details - K963433

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K963433
Device Name Pin, Fixation, Threaded
Applicant ORTHOPAEDIC BIOSYSTEMS, LTD.
7320 EAST BUTHERUS
SUITE 206
SCOTSDALE, AZ 85260 US
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Contact JEFFRY B SKIBA
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 08/30/1996
Decision Date 11/06/1996
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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