FDA Product Code
FDA Product Code JDK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3300
510(k) Clearances — 54 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K210062 | Mectaplug PE II | Medacta International S.A. | 2021-04-08 | Traditional | PDF ↗ |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Kinetikos Medical, Inc. | 2006-10-05 | Traditional | PDF ↗ |
| K061698 | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-07-12 | Special | PDF ↗ |
| K060247 | LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-05-11 | Traditional | PDF ↗ |
| K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM | Spinal USA | 2006-03-16 | Traditional | PDF ↗ |
| K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR | Interbody Innovations, Llp | 2005-12-06 | Traditional | PDF ↗ |
| K051836 | SKELITE RESORBABLE CEMENT RESTRICTOR | Millenium Biologix, Inc. | 2005-11-21 | Traditional | PDF ↗ |
| K051607 | NOVASPINE CEMENT RESTRICTOR NSCR | Novaspine, LLC | 2005-10-07 | Traditional | PDF ↗ |
| K052367 | SCIENT'X CEMENT RESTRICTOR | Scient'X | 2005-10-05 | Traditional | PDF ↗ |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2005-06-17 | Traditional | PDF ↗ |
| K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 | Amedica Corp. | 2005-04-15 | Special | PDF ↗ |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | Innovasis, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K033953 | OPTIMESH 500E CEMENT RESTRICTOR | Spineology, Inc. | 2004-07-06 | Traditional | PDF ↗ |
| K040276 | QUANTUM CEMENT RESTRICTOR | Quantum Orthopedics | 2004-04-30 | Traditional | PDF ↗ |
| K030767 | FIDJI SMALL CEMENT RESTRICTOR | Spine Next SA | 2003-12-22 | Traditional | PDF ↗ |
| K030871 | FIDJI LARGE CEMENT RESTRICTOR | Spine Next SA | 2003-12-22 | Traditional | PDF ↗ |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | Implex Corp. | 2003-11-19 | Special | PDF ↗ |
| K032180 | NUVASIVE CEMENT RESTRICTOR | Nuvasive, Inc. | 2003-10-07 | Traditional | PDF ↗ |
| K031318 | TRAXIS CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-08-22 | Special | PDF ↗ |
| K032095 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-08-08 | Special | PDF ↗ |
| K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2003-07-24 | Special | PDF ↗ |
| K030608 | OTI BONE CEMENT PLUG | Osteoimplant Technology, Inc. | 2003-06-12 | Traditional | PDF ↗ |
| K023908 | INTERPORE CROSS CEMENT RESTRICTOR | Interpore Cross Intl. | 2003-05-16 | Traditional | PDF ↗ |
| K023647 | CADENCE PEEK CEMEENT RESTRICTOR | Spinal Concepts, Inc. | 2002-11-27 | Special | PDF ↗ |
| K022615 | CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR | Centerpulse Spine-Tech, Inc. | 2002-10-29 | Special | PDF ↗ |
| K021788 | NBD CEMENT RESTRICTOR DEVICE | New Business Development, LLC | 2002-10-04 | Traditional | PDF ↗ |
| K021765 | CEMENT RESTRICTOR, SMALL AND LARGE | Exactech, Inc. | 2002-08-16 | Traditional | PDF ↗ |
| K021719 | FORTITUDE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-15 | Traditional | PDF ↗ |
| K022218 | CADENCE CEMENT RESTRICTOR | Spinal Concepts, Inc. | 2002-08-12 | Traditional | PDF ↗ |
| K020836 | RABEA CEMENT RESTRICTOR | Signus Medical, LLC | 2002-06-11 | Traditional | PDF ↗ |
| K020344 | RPX TITANIUM CEMNT RESTRICTOR | Sulzer Spine-Tech | 2002-05-02 | Traditional | PDF ↗ |
| K013663 | CEMENT RESTRICTOR | Medtronic Sofamor Danek, Inc. | 2001-12-05 | Special | PDF ↗ |
| K012462 | THEKEN LARGE CEMENT RESTRICTOR | Theken Surgical,Llc | 2001-10-29 | Traditional | PDF ↗ |
| K012278 | THEKEN SMALL CEMENT RESTRICTOR | Theken Surgical,Llc | 2001-10-17 | Traditional | PDF ↗ |
| K010528 | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK | Medtronic Sofamor Danek USA, Inc. | 2001-10-10 | Traditional | PDF ↗ |
| K013014 | BLOCK CEMENT RESTRICTOR (CR) - TITANIUM | Medtronic Sofamor Danek, Inc. | 2001-10-04 | Special | PDF ↗ |
| K011443 | THREADED CEMENT RESTRICTOR (CR) TITANIUM | Medtronic Sofamor Danek USA, Inc. | 2001-08-03 | Traditional | PDF ↗ |
| K012255 | MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR | Medtronic Sofamor Danek, Inc. | 2001-08-01 | Special | PDF ↗ |
| K011998 | METRONIC SOFAMOR DANEK CEMENT RESTRICTOR | Medtronic Sofamor Danek, Inc. | 2001-07-26 | Special | PDF ↗ |
| K003718 | TITANIUM CEMENT RESTRICTOR (TCR) | Medtronic Sofamor Danek, Inc. | 2001-02-14 | Traditional | PDF ↗ |
| K990345 | RABEA DEVICE, MODEL PXXXXXX | Signus Medizintechnik GmbH | 1999-07-30 | Traditional | PDF ↗ |
| K965056 | OSTEONICS SCREW HOLE PLUGS | Osteonics Corp. | 1997-02-28 | Traditional | PDF ↗ |
| K926216 | BONE CEMENT RESTRICTOR | Biodynamic Technologies, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K923616 | OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR | Osteonics Corp. | 1992-10-30 | Traditional | PDF ↗ |
| K911338 | LIMA CEMENT RESTRICTOR | Turnkey Intergration USA, Inc. | 1991-06-28 | Traditional | PDF ↗ |
| K910461 | OSTEONICS(R) MID-SHAFT CEMENT SPACER | Osteonics Corp. | 1991-04-08 | Traditional | PDF ↗ |
| K904746 | S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER | Joint Medical Products Corp. | 1990-11-20 | Traditional | PDF ↗ |
| K900462 | OSTEONICS CEMENT RESTRICTOR | Osteonics Corp. | 1990-03-06 | Traditional | PDF ↗ |
| K895378 | PROXIMAL CEMENT SPACER | Osteonics Reconstructive Products Div. | 1989-11-22 | Traditional | PDF ↗ |
| K894708 | PT DISTAL TIP CEMENT SPACER | Osteonics Corp. | 1989-10-10 | Traditional | PDF ↗ |
| K872528 | OMNIFIT DISTAL STEM CEMENT SPACERS | Osteonics Corp. | 1987-12-29 | Traditional | PDF ↗ |
| K840413 | CEMENT RESTRICTOR | American Ortomed Corp. | 1984-03-05 | Traditional | PDF ↗ |
| K831512 | DOSIMETRY RELEASE OF RADIATION STERILIZ | Biomet, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K831128 | BARD INTRAMEDULLARY PLUG | C.R. Bard, Inc. | 1983-07-12 | Traditional | PDF ↗ |
Product code JDK · Class II · General, Plastic Surgery. Data: openFDA.