Fx Shoulder USA, Inc.
Dallas, TX, US
Fx Shoulder USA, Inc. appears in FDA device records in Dallas, TX. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Fx Shoulder USA, Inc. between 2019 and 2024. The busiest year on record is 2020, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240278 | Full Wedge Lateralized and Augmented Baseplates | PHX | Substantially Equivalent | |
| K223801 | FX V135(TM) Shoulder Prosthesis | PHX | Substantially Equivalent | |
| K222936 | Humeris® 135 Shoulder System | PHX | Substantially Equivalent | |
| K213117 | FX V135 Shoulder Prosthesis | PHX | Substantially Equivalent | |
| K210790 | Lateralized and Augmented Baseplates | PHX | Substantially Equivalent | |
| K201391 | Easytech® Anatomical Shoulder System | PKC | Substantially Equivalent | |
| K191698 | TiN Coated Humeral Head | KWT | Substantially Equivalent | |
| K191146 | Humelock TiN Coated Glenosphere | PHX | Substantially Equivalent | |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | PHX | Substantially Equivalent | |
| K192799 | Glenoid Baseplate with Screw | PHX | Substantially Equivalent | |
| K192206 | 32mm Glenosphere and Humeral Cup | PHX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain