FDA.reportPublic FDA data

Humeral head spacer

Definition
A sterile implantable component of a total shoulder prosthesis intended to be placed between a standard humeral body and a standard humeral head to serve as a spacer and to achieve the intended varus/valgus alignment. It is in the form of a thick disc with a central or eccentric hole, is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo), or titanium (Ti)], and is used in a modular shoulder replacement system.
GUDID devices
50
Last updated
2026-07-17 22:01:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03701037317877HUMERIS 135FX SOLUTIONS313-00072026-06-25
08033390271455SMR SystemLIMACORPORATE SPA1330.15.2702024-02-22
08033390271462SMR SystemLIMACORPORATE SPA1331.15.2702024-02-22
08033390271981SMR SystemLIMACORPORATE SPA1330.15.2722024-02-22
08033390271998SMR SystemLIMACORPORATE SPA1330.15.2742024-02-22
08033390272001SMR SystemLIMACORPORATE SPA1330.15.2762024-02-22
08033390272018SMR SystemLIMACORPORATE SPA1330.15.2782024-02-22
08033390272100SMR SystemLIMACORPORATE SPA1331.15.2722024-02-22
08033390272148SMR SystemLIMACORPORATE SPA1331.15.2742024-02-22
08033390272155SMR SystemLIMACORPORATE SPA1331.15.2762024-02-22
08033390272186SMR SystemLIMACORPORATE SPA1331.15.2782024-02-22
08033390272476SMR SystemLIMACORPORATE SPA1352.15.2002024-02-22
08033390107723SMR STEMLESSLIMACORPORATE SPA1335.15.2002023-05-26
08033390107730SMR STEMLESSLIMACORPORATE SPA1335.15.2022023-05-26
08033390107778SMR STEMLESSLIMACORPORATE SPA1335.15.2042023-05-26
08033390201780PRIMALIMACORPORATE SPA1367.15.7002022-03-15
08033390201827PRIMALIMACORPORATE SPA1367.15.7022022-03-15
08033390201834PRIMALIMACORPORATE SPA1367.15.7042022-03-15
08033390201841PRIMALIMACORPORATE SPA1367.15.7062022-03-15
04026575198085LINK Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG642-010/012021-10-07
04026575235919LINK Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG642-010/002021-10-07
04026575235933LINK Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG642-010/022021-10-07
04026575236084LINK Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG642-010/042021-10-07
04026575236114LINK Embrace Shoulder SystemWALDEMAR LINK GmbH & Co. KG642-010/062021-10-07
03701037300770Humelock II Cemented Reversible ShoulderFX SOLUTIONS112-01002016-06-09
00846832060146Aequalis™ Adjustable ReversedTORNIER, INC.65009002015-09-22
00846832060153Aequalis™ Adjustable ReversedTORNIER, INC.65009152015-09-22
00846832060160Aequalis™ Adjustable ReversedTORNIER, INC.65009202015-09-22
00846832060177Aequalis™ Adjustable ReversedTORNIER, INC.65009252015-09-22
00846832060184Aequalis™ Adjustable ReversedTORNIER, INC.65009502015-09-22
00846832060191Aequalis™ Adjustable ReversedTORNIER, INC.65011002015-09-22
00846832060207Aequalis™ Adjustable ReversedTORNIER, INC.65011152015-09-22
00846832060214Aequalis™ Adjustable ReversedTORNIER, INC.65011202015-09-22
00846832060221Aequalis™ Adjustable ReversedTORNIER, INC.65011252015-09-22
00846832060238Aequalis™ Adjustable ReversedTORNIER, INC.65011502015-09-22
00846832060245Aequalis™ Adjustable ReversedTORNIER, INC.65013002015-09-22
00846832060252Aequalis™ Adjustable ReversedTORNIER, INC.65013152015-09-22
00846832060269Aequalis™ Adjustable ReversedTORNIER, INC.65013202015-09-22
00846832060276Aequalis™ Adjustable ReversedTORNIER, INC.65013252015-09-22
00846832060283Aequalis™ Adjustable ReversedTORNIER, INC.65013502015-10-16
00846832060290Aequalis™ Adjustable ReversedTORNIER, INC.65015002015-10-16
00846832060306Aequalis™ Adjustable ReversedTORNIER, INC.65015152015-10-16
00846832060313Aequalis™ Adjustable ReversedTORNIER, INC.65015202015-10-16
00846832060320Aequalis™ Adjustable ReversedTORNIER, INC.65015252015-10-16
00846832060337Aequalis™ Adjustable ReversedTORNIER, INC.65015502015-10-16
00846832060344Aequalis™ Adjustable ReversedTORNIER, INC.65017002015-10-16
00846832060351Aequalis™ Adjustable ReversedTORNIER, INC.65017152015-10-16
00846832060368Aequalis™ Adjustable ReversedTORNIER, INC.65017202015-10-16
00846832060375Aequalis™ Adjustable ReversedTORNIER, INC.65017252015-10-16
00846832060382Aequalis™ Adjustable ReversedTORNIER, INC.65017502015-10-16