Lateralized And Augmented Baseplates

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 Lateralized And Augmented Baseplates.

Pre-market Notification Details

Device IDK210790
510k NumberK210790
Device Name:Lateralized And Augmented Baseplates
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  
CFR Regulation Number888.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-16
Decision Date2021-08-25

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