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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 K161166
Device Name StageOne Select Cement Spacer Molds for Temporary Hip Replacement
Applicant
BIOMET, INC.
56 EAST BELL DRIVE
Warsaw,  IN  46581
Applicant Contact Carmen Albany
Correspondent
BIOMET, INC.
56 EAST BELL DRIVE
Warsaw,  IN  46581
Correspondent Contact Heidi Busz
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Codes
KWL   KWY  
Date Received04/26/2016
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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