FDA.reportPublic FDA data

Uncoated elbow humerus prosthesis

Definition
A sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.
GUDID devices
70
Last updated
2023-03-20 08:19:42

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08033390173186TEMA ElbowLIMACORPORATE SPA1550.15.1102023-03-10
08033390173230TEMA ElbowLIMACORPORATE SPA1550.15.1112023-03-10
08033390175449TEMA ElbowLIMACORPORATE SPA1550.15.1202023-03-10
08033390175456TEMA ElbowLIMACORPORATE SPA1550.15.1212023-03-10
08033390126458TEMA ElbowLIMACORPORATE SPA1550.15.0102019-05-24
08033390126922TEMA ElbowLIMACORPORATE SPA1550.15.0202019-05-24
08033390128810TEMA ElbowLIMACORPORATE SPA1504.14.0602019-05-24
08033390128827TEMA ElbowLIMACORPORATE SPA1504.14.1002019-05-24
08033390128889TEMA ElbowLIMACORPORATE SPA1550.15.9002019-05-24
08033390140065TEMA ElbowLIMACORPORATE SPA1550.15.0112019-05-24
08033390140171TEMA ElbowLIMACORPORATE SPA1504.14.0612019-05-24
08033390140201TEMA ElbowLIMACORPORATE SPA1504.14.0702019-05-24
08033390140218TEMA ElbowLIMACORPORATE SPA1504.14.0712019-05-24
08033390140225TEMA ElbowLIMACORPORATE SPA1504.14.0802019-05-24
08033390140232TEMA ElbowLIMACORPORATE SPA1504.14.0812019-05-24
08033390140249TEMA ElbowLIMACORPORATE SPA1504.14.0902019-05-24
08033390140256TEMA ElbowLIMACORPORATE SPA1504.14.0912019-05-24
08033390140263TEMA ElbowLIMACORPORATE SPA1504.14.1012019-05-24
08033390140287TEMA ElbowLIMACORPORATE SPA1550.15.0212019-05-24
07613327013993Total ElbowHowmedica Osteonics Corp.5003-15102015-09-24
07613327014006Total ElbowHowmedica Osteonics Corp.5003-000L2015-09-24
07613327014013Total ElbowHowmedica Osteonics Corp.5003-15122015-09-24
07613327014105Total ElbowHowmedica Osteonics Corp.5003-000S2015-09-24
00880304215672DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148902015-10-24
00880304215689DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148912015-10-24
00880304215696DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148922015-10-24
00880304215702DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148932015-10-24
00880304215719DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148942015-10-24
00880304215726DISCOVERY-MOSAIC ELBOW SYSTEMBiomet Orthopedics, LLC1148952015-10-24
00880304215849DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149342015-10-24
00880304215856DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149352015-10-24
00880304215863DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149362015-10-24
00880304215870DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149372015-10-24
00880304215887DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149382015-10-24
00880304215894DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149392015-10-24
00880304215900DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149442015-10-24
00880304215917DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149452015-10-24
00880304215924DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149462015-10-24
00880304215931DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149472015-10-24
00880304215948DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149482015-10-24
00880304215955DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149492015-10-24
00880304540842Comprehensive® SRSBiomet Orthopedics, LLC2112702015-10-24
00880304540859Comprehensive® SRSBiomet Orthopedics, LLC2112692015-10-24
00880304683297COMPREHENSIVE SRSBiomet Orthopedics, LLC2112722015-10-24
00880304806009COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100298242016-02-22
00880304806016COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100298252016-02-22
00880304806023COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100298262016-02-22
00880304806030COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100299382016-02-22
00880304806047COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100299392016-02-22
00880304806054COMPREHENSIVE® SRS / NEXELBiomet Orthopedics, LLC1100299402016-02-22
00880304850309Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112502017-03-16
00880304850316Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112512017-03-16
00880304850323Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112522017-03-16
00880304850330Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112532017-03-20
00880304850347Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112542017-03-20
00880304850354Comprehensive® SRS / Discovery®Biomet Orthopedics, LLC2112552017-03-20
00880304850361Comprehensive® SRSBiomet Orthopedics, LLC1100298242017-03-16
00880304850378Comprehensive® SRSBiomet Orthopedics, LLC1100298252017-03-16
00880304850385Comprehensive® SRSBiomet Orthopedics, LLC1100298262017-03-16
00880304850392Comprehensive® SRSBiomet Orthopedics, LLC1100299382017-03-16
00880304850408Comprehensive® SRSBiomet Orthopedics, LLC1100299392017-03-16
00880304850415Comprehensive® SRSBiomet Orthopedics, LLC1100299402017-03-16
00886385023304RHEADStryker GmbH410-01002015-09-24
00886385023311RHEADStryker GmbH410-01012015-09-24
00886385023328RHEADStryker GmbH410-01022015-09-24
00886385023335RHEADStryker GmbH410-01032015-09-24
00886385025933UNI-ELBOWStryker GmbH410-00002015-09-24
00886385025940UNI-ELBOWStryker GmbH410-00012015-09-24
00886385025957UNI-ELBOWStryker GmbH410-00022015-09-24
00886385025964UNI-ELBOWStryker GmbH410-00032015-09-24