FDA 510(k) Application Details - K032052

Device Classification Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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510(K) Number K032052
Device Name Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant PLUS ORTHOPEDICS
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681-2700 US
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Contact J.D. WEBB
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Regulation Number 888.3530

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Classification Product Code HRY
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Date Received 07/02/2003
Decision Date 07/25/2003
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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