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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K954768
Device Name BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
Applicant
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact VALERIE GARDNER
Correspondent
Biologically Oriented Prostheses
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact VALERIE GARDNER
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LZY  
Date Received10/17/1995
Decision Date 01/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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