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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K053274
Device Name ANATOMICAL SHOULDER INVERSE/REVERSE
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact DALENE T BINKLEY
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT  
Date Received11/23/2005
Decision Date 01/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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