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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K181362
Device Name TEMA Elbow System
Applicant
Lima Corporate S.P.A.
Via Nazionale 52
San Daniele Del Friuli,  IT 33038
Applicant Contact Roberto Gabetta
Correspondent
Peoples & Associates Consulting, LLC
5010 Lodge Pole Lane
Fort Wayne,  IN  46814
Correspondent Contact Stephen Peoples
Regulation Number888.3150
Classification Product Code
JDC  
Subsequent Product Code
JDB  
Date Received05/23/2018
Decision Date 02/16/2019
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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