FDA.reportPublic FDA data

Coated 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 coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
110
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07613327502886SOLARHowmedica Osteonics Corp.C-M109-7-4002019-08-07
07613327502893SOLARHowmedica Osteonics Corp.C-M109-7-4012019-08-07
07613327504804SOLARHowmedica Osteonics Corp.C-M110-1-2002019-10-07
07613327504811SOLARHowmedica Osteonics Corp.C-M110-1-2012019-10-07
07613327590050Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.C-M113-1-3002022-03-23
07613327590074Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.C-M113-1-3012022-03-23
07613327668889Modular ElbowHowmedica Osteonics Corp.C-MM100639-012025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.C-MM100639-032025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.C-MM100639-022025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.C-MM100639-042025-02-24
07613327627404SOLARHowmedica Osteonics Corp.C-MM100315-002023-06-23
07613327627411SOLARHowmedica Osteonics Corp.C-MM100315-012023-06-23
07613327627428SOLARHowmedica Osteonics Corp.C-MM100315-032023-06-23
07613327627435SOLARHowmedica Osteonics Corp.C-MM100315-022023-06-23
07613327627244SOLARHowmedica Osteonics Corp.C-MM100328-002023-06-05
07613327627251SOLARHowmedica Osteonics Corp.C-MM100328-012023-06-05
37613327590051Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.C-M113-1-3002022-03-23
37613327590075Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.C-M113-1-3012022-03-23
00846832074686LATITUDE EV™TORNIER, INC.00307002020-08-12
00846832074693LATITUDE EV™TORNIER, INC.00307012020-08-12
00846832074747LATITUDE EV™TORNIER, INC.00307102020-08-12
00846832074754LATITUDE EV™TORNIER, INC.00307112020-08-12
00846832074808LATITUDE EV™TORNIER, INC.00307202020-08-12
00846832074815LATITUDE EV™TORNIER, INC.00307212020-08-12
00190446138167DJO SURGICALEncore Medical, L.P.600-99-0032022-01-21
00889024271340Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-044-102015-09-17
00889024271357Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-044-152015-09-17
00889024271364Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-045-102015-09-17
00889024271371Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-045-152015-09-17
00889024271388Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-046-102015-09-17
00889024271395Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-046-152015-09-17
00889024271401Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-055-152015-09-17
00889024271418Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-055-202015-09-24
00889024271425Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-056-152015-09-17
00889024271432Zimmer® Nexel® Total ElbowZimmer, Inc.00-8400-056-202015-09-17
07613327137507SOLARHowmedica Osteonics Corp.5005-003L2015-09-24
07613327137514SOLARHowmedica Osteonics Corp.5005-002L2015-09-24
07613327137538SOLARHowmedica Osteonics Corp.5005-003R2015-09-24
07613327137552SOLARHowmedica Osteonics Corp.5005-002R2015-09-24
07613327137569SOLARHowmedica Osteonics Corp.5005-012R2015-09-24
07613327137576SOLARHowmedica Osteonics Corp.5005-012L2015-09-24
07613327137583SOLARHowmedica Osteonics Corp.5005-202L2015-09-24
07613327137590SOLARHowmedica Osteonics Corp.5005-102L2015-09-24
07613327137606SOLARHowmedica Osteonics Corp.5005-102R2015-09-24
07613327137613SOLARHowmedica Osteonics Corp.5005-013L2015-09-24
07613327137620SOLARHowmedica Osteonics Corp.5005-202R2015-09-24
07613327137637SOLARHowmedica Osteonics Corp.5005-30352015-09-24
07613327137644SOLARHowmedica Osteonics Corp.5005-302R2015-09-24
07613327137651SOLARHowmedica Osteonics Corp.5005-20352015-09-24
07613327137705SOLARHowmedica Osteonics Corp.5005-013R2015-09-24
07613327137835SOLARHowmedica Osteonics Corp.5005-302L2015-09-24
07613327138221SOLARHowmedica Osteonics Corp.5005-30402015-09-24
07613327138306SOLARHowmedica Osteonics Corp.5005-20402015-09-24
07613327138412Modular ElbowHowmedica Osteonics Corp.5005-U-080L2015-09-24
07613327138450Modular ElbowHowmedica Osteonics Corp.5005-U-080R2015-09-24
07613327138467Modular ElbowHowmedica Osteonics Corp.5005-U-120L2015-09-24
07613327138474Modular ElbowHowmedica Osteonics Corp.5005-U-100L2015-09-24
07613327138481Modular ElbowHowmedica Osteonics Corp.5005-U-100R2015-09-24
07613327138498Modular ElbowHowmedica Osteonics Corp.5005-U-120R2015-09-24
07613327139167Modular ElbowHowmedica Osteonics Corp.6487-C-0452015-09-24
07613327139181Modular ElbowHowmedica Osteonics Corp.6487-H-0452015-09-24
07613327139198Modular ElbowHowmedica Osteonics Corp.6487-H-0502015-09-24
07613327139204Modular ElbowHowmedica Osteonics Corp.6487-C-0352015-09-24
07613327139211Modular ElbowHowmedica Osteonics Corp.6487-H-0402015-09-24
07613327139266Modular ElbowHowmedica Osteonics Corp.6487-K-0012015-09-24
07613327139303Modular ElbowHowmedica Osteonics Corp.6487-H-0552015-09-24
00880304000742DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149142015-10-24
00880304001107DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149062015-10-24
00880304005143DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149082015-10-24
00880304005150DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149162015-10-24
00880304215757DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149042015-10-24
00880304215764DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149052015-10-24
00880304215788DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149072015-10-24
00880304215795DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149092015-10-24
00880304215801DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149152015-10-24
00880304215818DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149172015-10-24
00880304215825DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149182015-10-24
00880304215832DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149192015-10-24
00880304430457DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149132015-10-24
00880304461390DISCOVERY ELBOW SYSTEMBiomet Orthopedics, LLC1149282015-10-24