Product code JDC
- Device name
- Prosthesis, Elbow, Constrained, Cemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3150
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019-02-16 |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | 2019-01-28 |
| K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016-02-03 |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015-04-23 |
| K123862 | ZIMMER NEXEL TOTAL ELBOW | Zimmer, Inc. | 2013-03-12 |
| K090473 | DISCOVERY ELBOW - X-SMALL | Biomet Manufacturing Corp | 2009-03-25 |
| K060696 | ACCLAIM TOTAL ELBOW SYSTEM | DePuy Orthopaedics, Inc. | 2006-04-14 |
| K053189 | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES | Zimmer, Inc. | 2005-12-09 |
| K051975 | POROUS COATED DISCOVERY ELBOW | Biomet, Inc. | 2005-09-06 |
| K042664 | LPS UPPER EXTREMITY | Depuy, Inc. | 2004-12-08 |
| K040389 | COONRAD/MORREY ELBOW CEMENT RESTRICTOR | Zimmer, Inc. | 2004-05-17 |
| K033280 | DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM | Biomet, Inc. | 2003-12-19 |
| K013042 | DISCOVERY ELBOW | Biomet Orthopedics, Inc. | 2001-10-10 |
| K003253 | BIOMET'S MINIMALLY CONSTRAINED ELBOW | Biomet, Inc. | 2001-01-12 |
| K000003 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2000-10-02 |
| K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES | Zimmer, Inc. | 2000-07-25 |
| K000683 | MODIFIED SINGLE AXLE TOTAL ELBOW | Biomet, Inc. | 2000-06-27 |
| K992656 | DEPUY TOTAL ELBOW SYSTEM | DePuy Orthopaedics, Inc. | 1999-11-05 |
| K983036 | SINGLE AXLE TOTAL ELBOW | Biomet, Inc. | 1999-04-30 |
| K982398 | BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW | Biomet, Inc. | 1998-08-11 |
| K980428 | BIOMET BIAXIAL TOTAL ELBOW | Biomet, Inc. | 1998-05-05 |
| K980502 | OSTEONICS TOTAL ELBOW SYSTEM | Osteonics Corp. | 1998-05-05 |
| K973357 | COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN | Zimmer, Inc. | 1998-03-02 |
| K955916 | TOWNLEY TOTAL ELBOW SYSTEM | Biologically Oriented Prostheses | 1996-08-08 |
| K901581 | GSB ELBOW | Allo Pro Corp. | 1990-10-22 |
| K904021 | PNEUMOTHORAX KIT, MODIFICATION | Arrow Intl., Inc. | 1990-10-09 |
| K883665 | COONRAD III TOTAL ELBOW | Zimmer, Inc. | 1989-02-03 |
| K872084 | POROCOAT MARK II TOTAL ELBOW | Depuy, Inc. | 1987-06-25 |
| K861680 | OSTEONICS ELBOW PROSTHESIS | Osteonics Corp. | 1986-06-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327668889 | Modular Elbow | Howmedica Osteonics Corp. | 2025-02-24 |
| 07613327668902 | Modular Elbow | Howmedica Osteonics Corp. | 2025-02-24 |
| 07613327668919 | Modular Elbow | Howmedica Osteonics Corp. | 2025-02-24 |
| 08033390126441 | TEMA Elbow | LIMACORPORATE SPA | 2023-01-25 |
| 07613327590050 | Axel Pin Assembly Standard Elbow | Howmedica Osteonics Corp. | 2022-03-23 |
| 07613327590074 | Bearing and Axle Bushing Assembly - Standard Elbow | Howmedica Osteonics Corp. | 2022-03-23 |
| 08033390128872 | TEMA Elbow | LIMACORPORATE SPA | 2021-05-11 |
| 08033390128865 | TEMA Elbow | LIMACORPORATE SPA | 2021-05-11 |
| 07613327504804 | SOLAR | Howmedica Osteonics Corp. | 2019-10-07 |
| 07613327504811 | SOLAR | Howmedica Osteonics Corp. | 2019-10-07 |
| 07613327502893 | SOLAR | Howmedica Osteonics Corp. | 2019-08-07 |
| 07613327502886 | SOLAR | Howmedica Osteonics Corp. | 2019-08-07 |
| 08033390138291 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138277 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138314 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138260 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138246 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138222 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138208 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138192 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138178 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138154 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138147 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138123 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138109 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138086 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128896 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128841 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390126458 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390126434 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |