FDA 510(k) Application Details - K020170

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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510(K) Number K020170
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant ENCORE ORTHOPEDICS, INC.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
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Contact JOANNA DROEGE
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 01/17/2002
Decision Date 02/11/2002
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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