Humelock TiN Coated Glenosphere

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 Humelock Tin Coated Glenosphere.

Pre-market Notification Details

Device IDK191146
510k NumberK191146
Device Name:Humelock TiN Coated Glenosphere
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 Received2019-04-30
Decision Date2020-07-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03701037300800 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300848 K191146 000
03701037300855 K191146 000
03701037300800 K191146 000
03701037300817 K191146 000
03701037300855 K191146 000

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