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LZN — Cement Obturator Class II

FDA Device Classification

FDA product code LZN covers "Cement Obturator", 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
LZN
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-NumberApplicantDevice NameDate
K220838howmedica osteonics, dba stryker orthopaedicsArtisan Bone Plug, Universal Cement RestrictorMay 20, 2022
K061824tornierTORNIER CEMENT RESTRICTORSeptember 14, 2006
K032685teknimedCEMSTOP CEMENT RESTRICTORNovember 26, 2003
K023680smith and nephewBIOBUCK CEMENT RESTRICTORNovember 19, 2002
K011943kensey nashIMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTORSeptember 19, 2001
K010840isotisSYNPLUGApril 20, 2001
K000587isotisSHUTTLE STOPMay 4, 2000
K993841encore orthopedicsCEMSTOP CEMENT RESTRICTORMay 4, 2000
K992462howmedica osteonicsOSTEONICS UNIVERSAL DISTAL CEMENT PLUGAugust 13, 1999
K972411turnkey intergration usaLINK CEMENT PLUGAugust 29, 1997
K970779osteonicsOSTEONICS TIBIAL TRAY SCREW HOLE PLUGSMay 9, 1997
K955632sunmedORTHOPLUG SOFT BONE DESIGNFebruary 27, 1996
K955631sunmedORTHOPLUG HARD BONE DESIGNFebruary 27, 1996
K955751orthopaedic innovationsPRIME FEMORAL CEMENT PLUGJanuary 26, 1996
K951930depuyCEMENTRALIZER DISTAL STEM CENTRALIZERJuly 11, 1995
K951934johnson and johnson professionalsPFC CEMENT RESTRICTORMay 16, 1995
K951860howmedicaHOWMEDICE BONE PLUGMay 16, 1995
K933077howmedicaEXETER INTRAMEDULLARY BONE PLUGMay 16, 1995
K943727landosBIOSTOP G BONE CEMENT RESTRICTORMay 11, 1995
K943378implexIMPLEX CEMENT RESTRICTOR SYSTEMSeptember 23, 1994

FDA data resources