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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 K181611
Device Name Comprehensive Reverse Shoulder System
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46580
Applicant Contact Dalene Binkley
Correspondent
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Correspondent Contact Dalene Binkley
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT   PAO  
Date Received06/19/2018
Decision Date 09/24/2018
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
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