JDB — Prosthesis, Elbow, Semi-Constrained, Cemented Class II
FDA product code JDB covers "Prosthesis, Elbow, Semi-Constrained, Cemented", a Class II medical device regulated under 21 CFR 888.3160. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |