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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K202969
Device Name Biomet Microfixation OmniMax MMF System
Applicant
Biomet Microfixation
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact Lauren Jasper
Correspondent
Biomet Microfixation
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact Lauren Jasper
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received09/30/2020
Decision Date 08/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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