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11 devices found
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Manufacturer: Fx Shoulder USA, Inc.
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Device · Manufacturer · Authorizations
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Class
Humeral Cup Stability & Humeral Cup 135/145o Stability
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K193394
Active
Cleared 29 Apr 2020
Active
510(k)
510(k)
II
Full Wedge Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K240278
Active
Cleared 15 May 2024
Active
510(k)
510(k)
II
32mm Glenosphere and Humeral Cup
Open recall
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K192206
Active
Cleared 8 Oct 2019
Active
510(k)
510(k)
II
Easytech® Anatomical Shoulder System
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K201391
Active
Cleared 16 Feb 2021
Active
510(k)
510(k)
II
Humelock TiN Coated Glenosphere
Open recall
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K191146
Active
Cleared 15 Jul 2020
Active
510(k)
510(k)
II
FX V135(TM) Shoulder Prosthesis
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K223801
Active
Cleared 5 Jun 2023
Active
510(k)
510(k)
II
TiN Coated Humeral Head
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K191698
Active
Cleared 16 Jul 2020
Active
510(k)
510(k)
II
FX V135 Shoulder Prosthesis
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K213117
Active
Cleared 7 Jun 2022
Active
510(k)
510(k)
II
Glenoid Baseplate with Screw
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K192799
Active
Cleared 21 Feb 2020
Active
510(k)
510(k)
II
Humeris® 135 Shoulder System
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K222936
Active
Cleared 7 Nov 2022
Active
510(k)
510(k)
II
Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K210790
Active
Cleared 25 Aug 2021
Active
510(k)
510(k)
II
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