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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K922841
Device Name BIOPRO MODULAR TIBIAL TRAY
Applicant
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Applicant Contact AL LIPPINCOTT
Correspondent
Biopro, Inc.
17 17th St.
Port Huron,  MI  48060
Correspondent Contact AL LIPPINCOTT
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/12/1992
Decision Date 09/21/1993
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
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