FDA 510(k) Application Details - K974911

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K974911
Device Name Pin, Fixation, Threaded
Applicant AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO, CA 92121 US
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Contact LOUISE FOCHT
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 12/31/1997
Decision Date 03/16/1998
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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