FDA 510(k) Application Details - K994143

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K994143
Device Name Pin, Fixation, Threaded
Applicant SMITH & NEPHEW, INC.
1450 BROOKS RD.
MEMPHIS, TN 38116 US
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Contact DAVID HENLEY
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 12/08/1999
Decision Date 02/18/2000
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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