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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
510(k) Number K050766
Device Name EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
Applicant
ZIMMER TRABECULAR
80 COMMERCE DR.
allendale,  NJ  07401
Applicant Contact marci halevi
Correspondent
ZIMMER TRABECULAR
80 COMMERCE DR.
allendale,  NJ  07401
Correspondent Contact marci halevi
Regulation Number878.4820
Classification Product Code
HWE  
Date Received03/25/2005
Decision Date 05/26/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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