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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Proximal Femoral, Implant
510(k) Number K781389
Device Name BIOMET CONCENTRIC HEX SCREW
Applicant
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIOMET, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3030
Classification Product Code
JDO  
Date Received08/10/1978
Decision Date 08/21/1978
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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