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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K213785
Device Name SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
Applicant
Limacorporate
Via Nazionale 52
Villanova Di San Daniele Del Friuli,  IT 33038
Applicant Contact Roberto Gabetta
Correspondent
Lima U.S.A., Inc.
2001 NE Green Oaks Blvd.
Suite 100
Arlington,  TX  76006
Correspondent Contact Lacey Harbour
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Codes
KWT   MBF   PHX  
Date Received12/06/2021
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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