FDA 510(k) Application Details - K020145

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

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510(K) Number K020145
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant ORTHOPAEDIC INNOVATIONS, INC.
6188 OLSON MEMORIAL HWY.
GOLDEN VALLEY, MN 55422 US
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Contact GREGORY M MERCURI
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 01/16/2002
Decision Date 04/15/2002
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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