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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K071577
Device Name BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
Applicant
Biomet Microfixation, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact KIM REED
Correspondent
Biomet Microfixation, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact KIM REED
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/08/2007
Decision Date 09/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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