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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 K211359
Device Name Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
Applicant
Tornier, Inc.
10801 Nesbitt Ave South
Bloomington,  MN  55437
Applicant Contact Lisa Stahl
Correspondent
Tornier, Inc.
10801 Nesbitt Ave South
Bloomington,  MN  55437
Correspondent Contact Lisa Stahl
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
KWS   QHE  
Date Received05/03/2021
Decision Date 11/12/2021
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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