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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/Polymer, Cemented
510(k) Number K903116
Device Name RM ISOELASTIC BEVELLED ACETABULAR CUP
Applicant
Robert Mathys Co.
C/O Mathis Corp. N. America
7 Great Valley Pkwy./Ste 223
Malvern,  PA  19355
Applicant Contact HEINZ E WICK
Correspondent
Robert Mathys Co.
C/O Mathis Corp. N. America
7 Great Valley Pkwy./Ste 223
Malvern,  PA  19355
Correspondent Contact HEINZ E WICK
Regulation Number888.3350
Classification Product Code
JDI  
Date Received07/16/1990
Decision Date 10/23/1990
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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