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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pin, Fixation, Smooth
510(k) Number K990291
Device Name LACTOSORB BONE PIN
Applicant
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact MICHELLE L MCKINLEY
Correspondent
BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact MICHELLE L MCKINLEY
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MAI  
Date Received01/29/1999
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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