FDA 510(k) Application Details - K960660

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

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510(K) Number K960660
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER, UT 84020 US
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Contact MICHELLE M PERRY
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 02/16/1996
Decision Date 05/08/1996
Decision SESE - SUBST EQUIV
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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