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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 Uncemented Acetabular Component)
510(k) Number K091973
Device Name METASUL TAPER LINERS, METASUL FEMORAL HEADS
Applicant
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact BENJAMIN C CURSON
Correspondent
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact BENJAMIN C CURSON
Regulation Number888.3330
Classification Product Code
KWA  
Date Received07/01/2009
Decision Date 11/17/2009
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
Recalls CDRH Recalls
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