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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 K200171
Device Name SMR TT Augmented Glenoid System
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Michela Zanotto
Correspondent
Lima U.S.A., Inc.
2001 NE Green
Arlington,  TX  76006
Correspondent Contact Lacey Harbour
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   KWT   MBF  
Date Received01/23/2020
Decision Date 11/19/2020
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
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