FDA 510(k) Application Details - K021714

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

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510(K) Number K021714
Device Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant PLUS ORTHOPEDICS
6055 LUSK BLVD.
SAN DIEGO, CA 92121-2700 US
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Contact HARTMUT LOCH
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Regulation Number 888.3510

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Classification Product Code KRO
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Date Received 05/24/2002
Decision Date 06/21/2002
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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