Tornier Perform Humeral System – Stemless

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

Tornier, Inc.

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

Pre-market Notification Details

Device IDK220418
510k NumberK220418
Device Name:Tornier Perform Humeral System – Stemless
ClassificationProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Applicant Tornier, Inc. 10801 Nesbitt Ave South Bloomington,  MN  55437
ContactRenee Stoffel
CorrespondentRenee Stoffel
Tornier, Inc. 10801 Nesbitt Ave South Bloomington,  MN  55437
Product CodePKC  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-14
Decision Date2022-09-14

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