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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 K162800
Device Name BLUEPRINT Patient Specific Instrumentation
Applicant
TORNIER SAS
161 rue LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Applicant Contact Aymen AZAIEZ
Correspondent
TORNIER SAS
161 rue LAVOISIER
MONTBONNOT SAINT MARTIN,  FR 38330
Correspondent Contact Aymen AZAIEZ
Regulation Number888.3660
Classification Product Code
KWS  
Date Received10/05/2016
Decision Date 02/22/2017
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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