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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, semi-constrained, cemented
510(k) Number K193247
Device Name LATITUDE EV™ Total Elbow Arthroplasty
Applicant
Tornier Inc.
10801 Nesbitt Ave South
Bloomington,  MN  55347
Applicant Contact Renee Stoffel
Correspondent
Tornier Inc.
10801 Nesbitt Ave South
Bloomington,  MN  55347
Correspondent Contact Renee Stoffel
Regulation Number888.3160
Classification Product Code
JDB  
Subsequent Product Code
JDC  
Date Received11/25/2019
Decision Date 08/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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