JDC — Prosthesis, Elbow, Constrained, Cemented Class II
FDA Device Classification
Classification Details
- Product Code
- JDC
- Device Class
- Class II
- Regulation Number
- 888.3150
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K181362 | lima corporate | TEMA Elbow System | February 16, 2019 |
| K181307 | zimmer | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | January 28, 2019 |
| K153398 | biomet manufacturing | Comprehensive SRS/Nexel Elbow | February 3, 2016 |
| K150501 | zimmer | Zimmer Nexel Total Elbow Ulnar Cement Diverter | April 23, 2015 |
| K123862 | zimmer | ZIMMER NEXEL TOTAL ELBOW | March 12, 2013 |
| K090473 | biomet manufacturing | DISCOVERY ELBOW - X-SMALL | March 25, 2009 |
| K060696 | depuy orthopaedics | ACCLAIM TOTAL ELBOW SYSTEM | April 14, 2006 |
| K053189 | zimmer | COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES | December 9, 2005 |
| K051975 | biomet | POROUS COATED DISCOVERY ELBOW | September 6, 2005 |
| K042664 | depuy | LPS UPPER EXTREMITY | December 8, 2004 |
| K040389 | zimmer | COONRAD/MORREY ELBOW CEMENT RESTRICTOR | May 17, 2004 |
| K033280 | biomet | DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM | December 19, 2003 |
| K013042 | biomet orthopedics | DISCOVERY ELBOW | October 10, 2001 |
| K003253 | biomet | BIOMET'S MINIMALLY CONSTRAINED ELBOW | January 12, 2001 |
| K000003 | tornier | TORNIER TOTAL ELBOW PROSTHESIS | October 2, 2000 |
| K001989 | zimmer | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES | July 25, 2000 |
| K000683 | biomet | MODIFIED SINGLE AXLE TOTAL ELBOW | June 27, 2000 |
| K992656 | depuy orthopaedics | DEPUY TOTAL ELBOW SYSTEM | November 5, 1999 |
| K983036 | biomet | SINGLE AXLE TOTAL ELBOW | April 30, 1999 |
| K982398 | biomet | BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW | August 11, 1998 |