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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K992301
Device Name REUNITE SCREWS
Applicant
BIOMET MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact MICHELLE L MCKINLEY
Correspondent
BIOMET MANUFACTURING, INC.
AIRPORT INDUSTRIAL PARK
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact MICHELLE L MCKINLEY
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
MAI  
Date Received07/08/1999
Decision Date 09/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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