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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 K222760
Device Name StageOne™ Select Hip Cement Spacer Molds
Applicant
Biomet, Inc.
56 East Bell Drive, P.O. Box 587
Warsaw,  IN  46581
Applicant Contact Meredith Reed
Correspondent
Biomet, Inc.
56 East Bell Drive, P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact Meredith Reed
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Codes
KWL   KWY  
Date Received09/13/2022
Decision Date 12/28/2022
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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