Panels › General, Plastic Surgery › Product code JDK · Class 2
Prosthesis, Hip, Cement Restrictor
Regulation 878.3300
0510(k)s in 12 months (54 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in JDK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 7 | 0 |
| Encore Medical, Lp | 0 | 6 |
| Osteonics Corp. | 6 | 0 |
| Depuy Orthopaedics, Inc. | 0 | 5 |
| Spinal Concepts, Inc. | 5 | 0 |
| Interpore Cross Intl. | 2 | 0 |
| Life Spine | 2 | 0 |
| Spine Next SA | 2 | 0 |
| Theken Surgical,Llc | 2 | 0 |
| Amedica Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 2021 | K210062 | Mectaplug PE II Medacta International S.A., CH | JDK |
| Oct 5, 2006 | K061465 | KMI CEMENT RESTRICTOR IMPLANT Kinetikos Medical, Inc. | JDK |
| Jul 12, 2006 | K061698 | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR Life Spine | JDK |
| May 11, 2006 | K060247 | LIFE SPINE CEMENT RESTRICTOR Life Spine | JDK |
| Mar 16, 2006 | K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM Spinal USA | JDK |
| Dec 6, 2005 | K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR Interbody Innovations, Llp | JDK |
| Nov 21, 2005 | K051836 | SKELITE RESORBABLE CEMENT RESTRICTOR Millenium Biologix, Inc. | JDK |
| Oct 7, 2005 | K051607 | NOVASPINE CEMENT RESTRICTOR NSCR Novaspine, LLC | JDK |
| Oct 5, 2005 | K052367 | SCIENT'X CEMENT RESTRICTOR Scient'X | JDK |
| Jun 17, 2005 | K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE Osteobiologics, Inc. | JDK |
| Apr 15, 2005 | K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 Amedica Corp. | JDK |
| Jul 22, 2004 | K041583 | PEEK CEMENT RESTRICTOR X-BOX Innovasis, Inc. | JDK |
| Jul 6, 2004 | K033953 | OPTIMESH 500E CEMENT RESTRICTOR Spineology, Inc. | JDK |
| Apr 30, 2004 | K040276 | QUANTUM CEMENT RESTRICTOR Quantum Orthopedics | JDK |
| Dec 22, 2003 | K030871 | FIDJI LARGE CEMENT RESTRICTOR Spine Next SA | JDK |
| Dec 22, 2003 | K030767 | FIDJI SMALL CEMENT RESTRICTOR Spine Next SA | JDK |
| Nov 19, 2003 | K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ Implex Corp. | JDK |
| Oct 7, 2003 | K032180 | NUVASIVE CEMENT RESTRICTOR Nuvasive, Inc. | JDK |
| Aug 22, 2003 | K031318 | TRAXIS CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Aug 8, 2003 | K032095 | INTERPORE CROSS CEMENT RESTRICTOR Interpore Cross Intl. | JDK |
| Jul 24, 2003 | K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Jun 12, 2003 | K030608 | OTI BONE CEMENT PLUG Osteoimplant Technology, Inc. | JDK |
| May 16, 2003 | K023908 | INTERPORE CROSS CEMENT RESTRICTOR Interpore Cross Intl. | JDK |
| Nov 27, 2002 | K023647 | CADENCE PEEK CEMEENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Oct 29, 2002 | K022615 | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR Centerpulse Spine-Tech, Inc. | JDK |
| Oct 4, 2002 | K021788 | NBD CEMENT RESTRICTOR DEVICE New Business Development, LLC | JDK |
| Aug 16, 2002 | K021765 | CEMENT RESTRICTOR, SMALL AND LARGE Exactech, Inc. | JDK |
| Aug 15, 2002 | K021719 | FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Aug 12, 2002 | K022218 | CADENCE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Jun 11, 2002 | K020836 | RABEA CEMENT RESTRICTOR Signus Medical, LLC | JDK |
| May 2, 2002 | K020344 | RPX TITANIUM CEMNT RESTRICTOR Sulzer Spine-Tech | JDK |
| Dec 5, 2001 | K013663 | CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. | JDK |
| Oct 29, 2001 | K012462 | THEKEN LARGE CEMENT RESTRICTOR Theken Surgical,Llc | JDK |
| Oct 17, 2001 | K012278 | THEKEN SMALL CEMENT RESTRICTOR Theken Surgical,Llc | JDK |
| Oct 10, 2001 | K010528 | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK Medtronic Sofamor Danek USA, Inc. | JDK |
| Oct 4, 2001 | K013014 | BLOCK CEMENT RESTRICTOR (CR) - TITANIUM Medtronic Sofamor Danek, Inc. | JDK |
| Aug 3, 2001 | K011443 | THREADED CEMENT RESTRICTOR (CR) TITANIUM Medtronic Sofamor Danek USA, Inc. | JDK |
| Aug 1, 2001 | K012255 | MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. | JDK |
| Jul 26, 2001 | K011998 | METRONIC SOFAMOR DANEK CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. | JDK |
| Feb 14, 2001 | K003718 | TITANIUM CEMENT RESTRICTOR (TCR) Medtronic Sofamor Danek, Inc. | JDK |
| Jul 30, 1999 | K990345 | RABEA DEVICE, MODEL PXXXXXX Signus Medizintechnik GmbH | JDK |
| Feb 28, 1997 | K965056 | OSTEONICS SCREW HOLE PLUGS Osteonics Corp. | JDK |
| Mar 22, 1994 | K926216 | BONE CEMENT RESTRICTOR Biodynamic Technologies, Inc. | JDK |
| Oct 30, 1992 | K923616 | OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR Osteonics Corp. | JDK |
| Jun 28, 1991 | K911338 | LIMA CEMENT RESTRICTOR Turnkey Intergration USA, Inc. | JDK |
| Apr 8, 1991 | K910461 | OSTEONICS(R) MID-SHAFT CEMENT SPACER Osteonics Corp. | JDK |
| Nov 20, 1990 | K904746 | S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER Joint Medical Products Corp. | JDK |
| Mar 6, 1990 | K900462 | OSTEONICS CEMENT RESTRICTOR Osteonics Corp. | JDK |
| Nov 22, 1989 | K895378 | PROXIMAL CEMENT SPACER Osteonics Reconstructive Products Div. | JDK |
| Oct 10, 1989 | K894708 | PT DISTAL TIP CEMENT SPACER Osteonics Corp. | JDK |
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