Fx Shoulder Solutions Inc.

FDA Device Registration & Listing · Addison, TX, US · Registration 3014128390

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014128390
FEI Number
3014128390
Entity Name
Fx Shoulder Solutions Inc.
City/State/Country
Addison, TX, US
Establishment Address
15920 Addison Rd, Suite 200, Addison, TX 75001, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
FX Shoulder Solutions (Owner Number: 10039598)
Owner / Operator Contact Address
1663 rue de Majornas, Viriat, FR-NOTA 01440, FR
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K213117
PMA Number
N/A

All Registered Proprietary Names

FX V135 Easytech Humeris® 135 Shoulder System FX V135 Shoulder Prosthesis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-05-14
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2026-05-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2026-05-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-05-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-12-05
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-12-05
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-12-05
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-06-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-06-08
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-06-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FX Shoulder Solutions
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009532798 Fx Shoulder Solutions SAS Viriat Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014128390. Last updated year: 2026. Please use registration number 3014128390 when referencing this establishment in official correspondence.
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