FDA.reportPublic FDA data

Humeral head spacer prosthesis trial

Definition
A copy of a final humeral head spacer designed to be used before primary or revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is disk-like in shape and made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
GUDID devices
46
Last updated
2026-06-11 06:05:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850011453544REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCRRTHD442026-06-01
03700386999055Aequalis Pyrocarbon Humeral HeadTORNIERMWF7632023-01-06
08033390038799SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038805SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038812SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038829SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038843SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038850SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038867SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390038874SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098236SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098465SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098472SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098489SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098496SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098502SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098519SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390098526SMR ShoulderLIMACORPORATE SPATrial Adaptor2016-04-05
08033390101806SMR SystemLIMACORPORATE SPA9013.62.0112025-09-06
08033390101813SMR SystemLIMACORPORATE SPA9013.62.0162025-09-06
08033390101820SMR SystemLIMACORPORATE SPA9013.62.0212025-09-06
08033390101837SMR SystemLIMACORPORATE SPA9013.62.1162025-09-06
08033390101844SMR SystemLIMACORPORATE SPA9013.62.1212025-09-06
08033390101851SMR SystemLIMACORPORATE SPA9013.65.0112025-09-06
08033390101868SMR SystemLIMACORPORATE SPA9013.65.0162025-09-06
08033390101875SMR SystemLIMACORPORATE SPA9013.65.0212025-09-06
08033390101882SMR SystemLIMACORPORATE SPA9013.65.1162025-09-06
08033390101899SMR SystemLIMACORPORATE SPA9013.65.1212025-09-06
00840097512860restor3d Veritas rTSA InstrumentationRestor3d, Inc.5500-37012025-08-01
00850011453001Remedy Spacer OSTEOREMEDIES, LLCRRTSHDSM 2022-12-05
00850011453018Remedy Spacer OSTEOREMEDIES, LLCRRTSHDMD 2022-12-05
00850011453025Remedy Spacer OSTEOREMEDIES, LLCRRTSHDLG 2022-12-05
03700386969218Aequalis Reversed IITORNIERMWB1902022-08-08
03700386969225Aequalis Reversed IITORNIERMWB1912022-08-08
00888867062351Arthrex®ARTHREX, INC.AR-9551-062018-06-02
00888867062368Arthrex®ARTHREX, INC.AR-9551-092018-06-02
00888867062375Arthrex®ARTHREX, INC.AR-9551-122018-06-02
00888867062382Arthrex®ARTHREX, INC.AR-9551-152018-06-02
00888867062399Arthrex®ARTHREX, INC.AR-9552-062018-06-02
00888867062405Arthrex®ARTHREX, INC.AR-9552-092018-06-02
00888867062412Arthrex®ARTHREX, INC.AR-9552-122018-06-02
00888867062429Arthrex®ARTHREX, INC.AR-9552-152018-06-02
00888867062436Arthrex®ARTHREX, INC.AR-9553-062018-06-02
00888867062443Arthrex®ARTHREX, INC.AR-9553-092018-06-02
00888867062450Arthrex®ARTHREX, INC.AR-9553-122018-06-02
00888867062467Arthrex®ARTHREX, INC.AR-9553-152018-06-02