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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K191711
Device Name ORTHOLOC™ SPS Shoulder Plating System
Applicant
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Renee Stoffel
Correspondent
Tornier, Inc.
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Renee Stoffel
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   KTT   KTW  
Date Received06/26/2019
Decision Date 07/17/2019
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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