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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 K161273
Device Name StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Applicant Contact Carmen Albany
Biomet, Inc.
56 East Bell Drive
Warsaw,  IN  46581
Correspondent Contact Heidi Busz
Regulation Number888.3027
Classification Product Code
Subsequent Product Code
Date Received05/05/2016
Decision Date 01/25/2017
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