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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K110542
FOIA Releasable 510(k) K110542
Device Name CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
Applicant
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Applicant Contact MATTHEW HULL
Correspondent
Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills,  CA  95762
Correspondent Contact MATTHEW HULL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received02/24/2011
Decision Date 04/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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