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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 K243761
Device Name A.L.P.S. Small Fragment Plating System
Applicant
Biomet Orthopedics
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact Tracy Johnson
Correspondent
Biomet Orthopedics
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Prerna Satavase
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received12/06/2024
Decision Date 02/19/2025
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
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