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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Semi-Constrained, Cemented
510(k) Number K983141
Device Name CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact DEANA BOUSHELL
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact DEANA BOUSHELL
Regulation Number888.3160
Classification Product Code
JDB  
Date Received09/08/1998
Decision Date 11/06/1998
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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