JDK — Prosthesis, Hip, Cement Restrictor Class II
FDA product code JDK covers "Prosthesis, Hip, Cement Restrictor", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery 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
- 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 |