Product code JDK
- Device name
- Prosthesis, Hip, Cement Restrictor
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3300
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210062 | Mectaplug PE II | Medacta International S.A. | 2021-04-08 |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Kinetikos Medical, Inc. | 2006-10-05 |
| K061698 | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-07-12 |
| K060247 | LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-05-11 |
| K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM | Spinal USA | 2006-03-16 |
| K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR | Interbody Innovations, Llp | 2005-12-06 |
| K051836 | SKELITE RESORBABLE CEMENT RESTRICTOR | Millenium Biologix, Inc. | 2005-11-21 |
| K051607 | NOVASPINE CEMENT RESTRICTOR NSCR | Novaspine, LLC | 2005-10-07 |
| K052367 | SCIENT'X CEMENT RESTRICTOR | Scient'X | 2005-10-05 |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2005-06-17 |
| K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 | Amedica Corp. | 2005-04-15 |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | Innovasis, Inc. | 2004-07-22 |
| K033953 | OPTIMESH 500E CEMENT RESTRICTOR | Spineology, Inc. | 2004-07-06 |
| K040276 | QUANTUM CEMENT RESTRICTOR | Quantum Orthopedics | 2004-04-30 |
| K030767 | FIDJI SMALL CEMENT RESTRICTOR | Spine Next SA | 2003-12-22 |
| K030871 | FIDJI LARGE CEMENT RESTRICTOR | Spine Next SA | 2003-12-22 |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | Implex Corp. | 2003-11-19 |
| K032180 | NUVASIVE CEMENT RESTRICTOR | Nuvasive, Inc. | 2003-10-07 |
| K031318 | TRAXIS CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-08-22 |
| K032095 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-08-08 |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-07-24 |
| K030608 | OTI BONE CEMENT PLUG | Osteoimplant Technology, Inc. | 2003-06-12 |
| K023908 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-05-16 |
| K023647 | CADENCE PEEK CEMEENT RESTRICTOR | Spinal Concepts, Inc. | 2002-11-27 |
| K022615 | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR | Centerpulse Spine-Tech, Inc. | 2002-10-29 |
| K021788 | NBD CEMENT RESTRICTOR DEVICE | New Business Development, LLC | 2002-10-04 |
| K021765 | CEMENT RESTRICTOR, SMALL AND LARGE | Exactech, Inc. | 2002-08-16 |
| K021719 | FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-15 |
| K022218 | CADENCE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-12 |
| K020836 | RABEA CEMENT RESTRICTOR | Signus Medical, LLC | 2002-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08031497002842 | MectaCem BonePrep | TECRES SPA | 2022-11-17 |
| 07630345711007 | MectaPlug PE II | Medacta International SA | 2021-04-16 |
| 07630345710994 | MectaPlug PE II | Medacta International SA | 2021-04-16 |
| 07630345710987 | MectaPlug PE II | Medacta International SA | 2021-04-16 |
| 07630345710970 | MectaPlug PE II | Medacta International SA | 2021-04-16 |
| 07630345710963 | MectaPlug PE II | Medacta International SA | 2021-04-16 |
| 08053369431048 | Emotec srl | EMOTEC SRL | 2021-02-03 |
| 08031497001418 | Cement Restrictor | TECRES SPA | 2015-10-12 |
| 08031497001579 | Cement Restrictor | TECRES SPA | 2015-10-12 |
| 08031497001562 | Cement Restrictor | TECRES SPA | 2015-10-12 |
| 08031497001401 | Cement Restrictor | TECRES SPA | 2015-10-12 |
| 10603295174592 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295174585 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295174561 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295174547 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295174608 | BIOSTOP | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 04546540039637 | BioPrep | STRYKER CORPORATION | 2015-09-23 |
| 10603295034568 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034551 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034544 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034537 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034520 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034513 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034506 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034490 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034483 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034476 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034469 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034452 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |
| 10603295034445 | CEMENTRALIZER | DEPUY (IRELAND) | 2015-03-24 |