JDK — Prosthesis, Hip, Cement Restrictor Class II
FDA Device Classification
Classification Details
- Product Code
- JDK
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- OR
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K210062 | medacta international | Mectaplug PE II | April 8, 2021 |
| K061465 | kinetikos medical | KMI CEMENT RESTRICTOR IMPLANT | October 5, 2006 |
| K061698 | life spine | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | July 12, 2006 |
| K060247 | life spine | LIFE SPINE CEMENT RESTRICTOR | May 11, 2006 |
| K060132 | spinal usa | SPINAL USA CEMENT RESTRICTOR SYSTEM | March 16, 2006 |
| K051371 | interbody innovations | INTERBODY INNOVATIONS CEMENT RESTRICTOR | December 6, 2005 |
| K051836 | millenium biologix | SKELITE RESORBABLE CEMENT RESTRICTOR | November 21, 2005 |
| K051607 | novaspine | NOVASPINE CEMENT RESTRICTOR NSCR | October 7, 2005 |
| K052367 | scient'x | SCIENT'X CEMENT RESTRICTOR | October 5, 2005 |
| K041382 | osteobiologics | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | June 17, 2005 |
| K050699 | amedica | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 | April 15, 2005 |
| K041583 | innovasis | PEEK CEMENT RESTRICTOR X-BOX | July 22, 2004 |
| K033953 | spineology | OPTIMESH 500E CEMENT RESTRICTOR | July 6, 2004 |
| K040276 | quantum orthopedics | QUANTUM CEMENT RESTRICTOR | April 30, 2004 |
| K030871 | spine next | FIDJI LARGE CEMENT RESTRICTOR | December 22, 2003 |
| K030767 | spine next | FIDJI SMALL CEMENT RESTRICTOR | December 22, 2003 |
| K033384 | implex | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | November 19, 2003 |
| K032180 | nuvasive | NUVASIVE CEMENT RESTRICTOR | October 7, 2003 |
| K031318 | spinal concepts | TRAXIS CEMENT RESTRICTOR | August 22, 2003 |
| K032095 | interpore cross intl | INTERPORE CROSS CEMENT RESTRICTOR | August 8, 2003 |