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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone cement, antibiotic
510(k) Number K213287
Device Name StageOne Knee Cement Spacer Molds
Applicant
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Anuja Yardi
Correspondent
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Neha Sreenath
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
JWH  
Date Received10/01/2021
Decision Date 09/02/2022
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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