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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K001046
Device Name BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
Applicant
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact CHERYL WARSINSKE
Correspondent
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact CHERYL WARSINSKE
Regulation Number888.3660
Classification Product Code
KWS  
Date Received03/31/2000
Decision Date 06/08/2000
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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