FDA 510(k) Application Details - K921836

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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510(K) Number K921836
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant ORTHOMET, INC.
6301 CECILIA CIRCLE
MINNEAPOLIS, MN US
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Contact DENNIS CRANE
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Regulation Number 888.3353

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Classification Product Code LZO
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Date Received 04/17/1992
Decision Date 11/06/1992
Decision SE - Substantially Equivalent
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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