Tornier Perform™ Patient-Matched Primary Reversed Glenoid And BLUEPRINT™ Patient Specific Instrumentation

Shoulder Prosthesis, Reverse Configuration

Tornier, Inc.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Perform™ Patient-matched Primary Reversed Glenoid And Blueprint™ Patient Specific Instrumentation.

Pre-market Notification Details

Device IDK211359
510k NumberK211359
Device Name:Tornier Perform™ Patient-Matched Primary Reversed Glenoid And BLUEPRINT™ Patient Specific Instrumentation
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant Tornier, Inc. 10801 Nesbitt Ave South Bloomington,  MN  55437
ContactLisa Stahl
CorrespondentLisa Stahl
Tornier, Inc. 10801 Nesbitt Ave South Bloomington,  MN  55437
Product CodePHX  
Subsequent Product CodeKWS
Subsequent Product CodeQHE
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-03
Decision Date2021-11-12

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