PERFORM Humeral System – Stem

Prosthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented

Tornier, Inc.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Perform Humeral System – Stem.

Pre-market Notification Details

Device IDK201315
510k NumberK201315
Device Name:PERFORM Humeral System – Stem
ClassificationProsthesis, Shoulder, Semi-constrained, Metal/polymer + Additive, Cemented
Applicant Tornier, Inc. 10801 Nesbitt Avenue South Bloomington,  MN  55437
ContactRenee Stoffel
CorrespondentRenee Stoffel
Tornier, Inc. 10801 Nesbitt Avenue South Bloomington,  MN  55437
Product CodePAO  
Subsequent Product CodeHSD
Subsequent Product CodeKWS
Subsequent Product CodeKWT
Subsequent Product CodePHX
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-18
Decision Date2020-09-11

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