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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K193373
Device Name Comprehensive® Reverse Shoulder
Applicant
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Applicant Contact Kari Hovorka
Correspondent
Biomet, Inc.
56 E. Bell Dr.,
P.O. Box 587
Warsaw,  IN  46581
Correspondent Contact Kari Hovorka
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received12/05/2019
Decision Date 04/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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