Product code JDK— General, Plastic Surgery
CEMENT RESTRICTOR
- Classification name
- Prosthesis, Hip, Cement Restrictor
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 54
- First cleared
- Most recent
Market context for product code JDK
FDA has cleared devices under product code JDK between 1983 and 2021, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2021
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
- 1999
- 1997
- 1994
- 1992
- 1991
- 1990
- 1989
- 1987
Top applicants under product code JDK
Recent clearances under product code JDK
- K210062 — Mectaplug PE II
- K061465 — KMI CEMENT RESTRICTOR IMPLANT
- K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
- K060247 — LIFE SPINE CEMENT RESTRICTOR
- K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM
- K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR
- K051836 — SKELITE RESORBABLE CEMENT RESTRICTOR
- K051607 — NOVASPINE CEMENT RESTRICTOR NSCR
- K052367 — SCIENT'X CEMENT RESTRICTOR
- K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
- K050699 — MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
- K041583 — PEEK CEMENT RESTRICTOR X-BOX
- K033953 — OPTIMESH 500E CEMENT RESTRICTOR
- K040276 — QUANTUM CEMENT RESTRICTOR
- K030767 — FIDJI SMALL CEMENT RESTRICTOR
- K030871 — FIDJI LARGE CEMENT RESTRICTOR
- K033384 — THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
- K032180 — NUVASIVE CEMENT RESTRICTOR
- K031318 — TRAXIS CEMENT RESTRICTOR
- K032095 — INTERPORE CROSS CEMENT RESTRICTOR
- K031837 — MODIFICATION TO FORTITUDE CEMENT RESTRICTOR
- K030608 — OTI BONE CEMENT PLUG
- K023908 — INTERPORE CROSS CEMENT RESTRICTOR
- K023647 — CADENCE PEEK CEMEENT RESTRICTOR
- K022615 — CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR
- K021788 — NBD CEMENT RESTRICTOR DEVICE
- K021765 — CEMENT RESTRICTOR, SMALL AND LARGE
- K021719 — FORTITUDE CEMENT RESTRICTOR
- K022218 — CADENCE CEMENT RESTRICTOR
- K020836 — RABEA CEMENT RESTRICTOR
- K020344 — RPX TITANIUM CEMNT RESTRICTOR
- K013663 — CEMENT RESTRICTOR
- K012462 — THEKEN LARGE CEMENT RESTRICTOR
- K012278 — THEKEN SMALL CEMENT RESTRICTOR
- K010528 — TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
- K013014 — BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
- K011443 — THREADED CEMENT RESTRICTOR (CR) TITANIUM
- K012255 — MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
- K011998 — METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
- K003718 — TITANIUM CEMENT RESTRICTOR (TCR)
- K990345 — RABEA DEVICE, MODEL PXXXXXX
- K965056 — OSTEONICS SCREW HOLE PLUGS
- K926216 — BONE CEMENT RESTRICTOR
- K923616 — OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR
- K911338 — LIMA CEMENT RESTRICTOR
- K910461 — OSTEONICS(R) MID-SHAFT CEMENT SPACER
- K904746 — S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
- K900462 — OSTEONICS CEMENT RESTRICTOR
- K895378 — PROXIMAL CEMENT SPACER
- K894708 — PT DISTAL TIP CEMENT SPACER
- K872528 — OMNIFIT DISTAL STEM CEMENT SPACERS
- K840413 — CEMENT RESTRICTOR
- K831512 — DOSIMETRY RELEASE OF RADIATION STERILIZ
- K831128 — BARD INTRAMEDULLARY PLUG
Data sourced from openFDA. This site is unofficial and independent of the FDA.