FDA 510(k) Applications for Medical Device Product Code: LZN (Cement Obturator)

FDA 510(k) Applications for Medical Device Product Code "LZN"
(Cement Obturator)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K993841	ENCORE ORTHOPEDICS, INC.	CEMSTOP CEMENT RESTRICTOR	05/04/2000
K992462	HOWMEDICA OSTEONICS CORP.	OSTEONICS UNIVERSAL DISTAL CEMENT PLUG	08/13/1999
K220838	Howmedica Osteonics, dba Stryker Orthopaedics	Artisan Bone Plug, Universal Cement Restrictor	05/20/2022
K000587	ISOTIS NV	SHUTTLE STOP	05/04/2000
K010840	ISOTIS NV	SYNPLUG	04/20/2001
K011943	KENSEY NASH CORP.	IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR	09/19/2001
K955751	ORTHOPAEDIC INNOVATIONS, INC.	PRIME FEMORAL CEMENT PLUG	01/26/1996
K970779	OSTEONICS CORP.	OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS	05/09/1997
K023680	SMITH & NEPHEW, INC.	BIOBUCK CEMENT RESTRICTOR	11/19/2002
K955631	SUNMED, INC.	ORTHOPLUG HARD BONE DESIGN	02/27/1996
K955632	SUNMED, INC.	ORTHOPLUG SOFT BONE DESIGN	02/27/1996
K032685	TEKNIMED SA	CEMSTOP CEMENT RESTRICTOR	11/26/2003
K061824	TORNIER	TORNIER CEMENT RESTRICTOR	09/14/2006
K972411	TURNKEY INTERGRATION USA, INC.	LINK CEMENT PLUG	08/29/1997