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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 K160071
Device Name StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
Applicant
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact Carmen Albany
Correspondent
Biomet, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Heidi Busz
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Codes
HSD   KWS  
Date Received01/13/2016
Decision Date 06/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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