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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K183162
Device Name Affixus Hip Fracture Nail
Applicant
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Dhaval Saraiya
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Dhaval Saraiya
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/15/2018
Decision Date 12/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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