Product code JDB
- Device name
- Prosthesis, Elbow, Semi-Constrained, Cemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3160
- 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 |
|---|---|---|---|
| K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022-10-26 |
| K193247 | LATITUDE EV™ Total Elbow Arthroplasty | Tornier, Inc. | 2020-08-05 |
| K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018-12-27 |
| K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017-08-31 |
| K102180 | RHEAD RADIAL HEAD EXTENDED STEMS | Small Bone Innovations, Inc. | 2010-12-20 |
| K100562 | LATITUDE ELBOW PROSTHESIS | Tornier, Inc. | 2010-06-29 |
| K070787 | LATITUDE ELBOW PROTHESIS | Tornier | 2007-08-24 |
| K070236 | SBI LATERAL RADIO CAPITELLUM | Small Bone Innovations, Inc. | 2007-02-21 |
| K060438 | RHS | Tornier | 2006-04-18 |
| K060038 | SBI RADIO-CAPITELLAR IMPLANT | Small Bone Innovations, Inc. | 2006-03-30 |
| K050848 | TORNIER ELBOW PROSTHESIS | Tornier | 2005-07-14 |
| K031218 | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2003-05-16 |
| K011567 | TORNIER TOTAL ELBOW PROSTHESIS | Tornier | 2001-06-19 |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Johnson & Johnson Professionals, Inc. | 1998-11-06 |
| K972691 | ABC TOTAL ELBOW PROTHESIS | Biomet, Inc. | 1997-10-15 |
| K960087 | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | Wrightmedicaltechnologyinc | 1996-09-20 |
| K955099 | SORBIE TOTAL ELBOW SYSTEM | Wrightmedicaltechnologyinc | 1996-02-05 |
| K880188 | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM | Howmedica Corp. | 1988-03-01 |
| K873660 | ROPER-TUKE ELBOW | Orthopedic Systems, Inc. | 1988-01-06 |
| K823473 | POROCOAT MARK IV ELBOW | Depuy, Inc. | 1983-01-20 |
| K820957 | SUFACE REPLACEMENT ELBOW | Howmedica Corp. | 1982-07-02 |
| K812322 | ARIZONA RADIO CAPITELLAR TOTAL ELBOW | Zimmer, Inc. | 1982-01-04 |
| K811451 | RADIAL HEAD PROSTHESIS | Cintor Orthopaedic Div. | 1981-06-09 |
| K810847 | PRITCHARD SURFACE REPLACEMENT ELBOW | Depuy, Inc. | 1981-05-01 |
| K802348 | TRIAXIAL | Johnson & Johnson Professionals, Inc. | 1981-02-23 |
| K802460 | HELFET ELBOW PROSTHESIS | Depuy, Inc. | 1980-11-19 |
| K801574 | DEPALMA ELBOW | Zimmer, Inc. | 1980-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033390138307 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138604 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138567 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138550 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138543 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138536 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138529 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138505 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138499 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138468 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138451 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138444 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138437 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138383 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138321 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390126465 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138284 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138253 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138239 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138215 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138185 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138130 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138116 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390138093 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128889 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128858 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128834 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128827 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390128810 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |
| 08033390126922 | TEMA Elbow | LIMACORPORATE SPA | 2019-05-24 |