JDB — Prosthesis, Elbow, Semi-Constrained, Cemented Class II
FDA Device Classification
Classification Details
- Product Code
- JDB
- Device Class
- Class II
- Regulation Number
- 888.3160
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K222807 | lima corporate | TEMA Elbow system - Line extension | October 26, 2022 |
| K193247 | tornier | LATITUDE EV Total Elbow Arthroplasty | August 5, 2020 |
| K182461 | tornier | LATITUDE EV Total Elbow Arthroplasty | December 27, 2018 |
| K171010 | tornier | Latitude EV Total Elbow Arthroplasty | August 31, 2017 |
| K102180 | small bone innovations | RHEAD RADIAL HEAD EXTENDED STEMS | December 20, 2010 |
| K100562 | tornier | LATITUDE ELBOW PROSTHESIS | June 29, 2010 |
| K070787 | tornier | LATITUDE ELBOW PROTHESIS | August 24, 2007 |
| K070236 | small bone innovations | SBI LATERAL RADIO CAPITELLUM | February 21, 2007 |
| K060438 | tornier | RHS | April 18, 2006 |
| K060038 | small bone innovations | SBI RADIO-CAPITELLAR IMPLANT | March 30, 2006 |
| K050848 | tornier | TORNIER ELBOW PROSTHESIS | July 14, 2005 |
| K031218 | tornier | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS | May 16, 2003 |
| K011567 | tornier | TORNIER TOTAL ELBOW PROSTHESIS | June 19, 2001 |
| K983141 | johnson and johnson professionals | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | November 6, 1998 |
| K972691 | biomet | ABC TOTAL ELBOW PROTHESIS | October 15, 1997 |
| K960087 | wrightmedicaltechnologyinc | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) | September 20, 1996 |
| K955099 | wrightmedicaltechnologyinc | SORBIE TOTAL ELBOW SYSTEM | February 5, 1996 |
| K880188 | howmedica | SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM | March 1, 1988 |
| K873660 | orthopedic systems | ROPER-TUKE ELBOW | January 6, 1988 |
| K823473 | depuy | POROCOAT MARK IV ELBOW | January 20, 1983 |