FX V135 Shoulder Prosthesis

Shoulder Prosthesis, Reverse Configuration

FX Shoulder USA, Inc.

The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Fx V135 Shoulder Prosthesis.

Pre-market Notification Details

Device IDK213117
510k NumberK213117
Device Name:FX V135 Shoulder Prosthesis
ClassificationShoulder Prosthesis, Reverse Configuration
Applicant FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas,  TX  75244
ContactKathy Trier
CorrespondentKathy Trier
FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas,  TX  75244
Product CodePHX  
Subsequent Product CodeHSD
Subsequent Product CodeKWT
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-27
Decision Date2022-06-07

NIH GUDID Devices

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