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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K002020
Device Name LACTOSORB MENISCAL SCREW
Applicant
BIOMET MANUFACTURING, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact MARY VERSTYNEN
Correspondent
BIOMET MANUFACTURING, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact MARY VERSTYNEN
Regulation Number888.3030
Classification Product Code
MAI  
Date Received07/03/2000
Decision Date 08/25/2000
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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