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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Carpal Trapezium
510(k) Number K964472
Device Name RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
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 Number888.3770
Classification Product Code
KYI  
Date Received11/07/1996
Decision Date 02/03/1997
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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