TiN Coated Humeral Head

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

FX Shoulder USA, Inc.

The following data is part of a premarket notification filed by Fx Shoulder Usa, Inc. with the FDA for Tin Coated Humeral Head.

Pre-market Notification Details

Device IDK191698
510k NumberK191698
Device Name:TiN Coated Humeral Head
ClassificationProsthesis, Shoulder, Non-constrained, Metal/polymer Cemented
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 CodeKWT  
CFR Regulation Number888.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-25
Decision Date2020-07-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03701037309582 K191698 000
03701037300886 K191698 000
03701037300893 K191698 000
03701037300909 K191698 000
03701037300916 K191698 000
03701037300923 K191698 000
03701037300930 K191698 000
03701037300954 K191698 000
03701037300961 K191698 000
03701037300978 K191698 000
03701037300985 K191698 000
03701037300992 K191698 000
03701037301005 K191698 000
03701037301012 K191698 000
03701037309575 K191698 000
03701037300879 K191698 000

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