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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 K944792
Device Name ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
Applicant
Zimmer, Inc.
508 And 727 N. Detroit St.
Warsaw,  IN  46580
Applicant Contact ANGIE IDE
Correspondent
Zimmer, Inc.
508 And 727 N. Detroit St.
Warsaw,  IN  46580
Correspondent Contact ANGIE IDE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received09/28/1994
Decision Date 04/26/1995
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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