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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K171054
Device Name Biomet Knee Joint Replacement Prostheses
Applicant
Biomet, Inc
56 East Bell Drive
warsaw,  IN  46581
Applicant Contact jason heckaman
Correspondent
Biomet, Inc
56 East Bell Drive
warsaw,  IN  46581
Correspondent Contact jason heckaman
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
HRY   MBH   MBV   OIY  
Date Received04/10/2017
Decision Date 07/28/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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