FDA.reportPublic FDA data

510(k) K011943

Device
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
Applicant
Kensey Nash Corp.
510(k) number
K011943
Product code
LZN
Decision
Substantially Equivalent (SESE)
Decision date
2001-09-19
Date received
2001-06-21
Regulation
878.3300
Classification name
Cement Obturator
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JULIE N BRODERICK
Address
55 E. Uwchlan Ave. Marsh Creek Corp. Center Exton PA US 19341 19341

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220838Artisan Bone Plug, Universal Cement RestrictorHowmedica Osteonics, Dba Stryker Orthopaedics2022-05-20
K061824TORNIER CEMENT RESTRICTORTornier2006-09-14
K032685CEMSTOP CEMENT RESTRICTORTeknimed, S.A.2003-11-26
K023680BIOBUCK CEMENT RESTRICTORSmith & Nephew, Inc.2002-11-19
K010840SYNPLUGIsotis NV2001-04-20
K993841CEMSTOP CEMENT RESTRICTOREncore Orthopedics, Inc.2000-05-04
K000587SHUTTLE STOPIsotis NV2000-05-04
K992462OSTEONICS UNIVERSAL DISTAL CEMENT PLUGHowmedica Osteonics Corp.1999-08-13
K972411LINK CEMENT PLUGTurnkey Intergration USA, Inc.1997-08-29
K970779OSTEONICS TIBIAL TRAY SCREW HOLE PLUGSOsteonics Corp.1997-05-09
K955632ORTHOPLUG SOFT BONE DESIGNSunmed, Inc.1996-02-27
K955631ORTHOPLUG HARD BONE DESIGNSunmed, Inc.1996-02-27
K955751PRIME FEMORAL CEMENT PLUGOrthopaedic Innovations, Inc.1996-01-26
K951930CEMENTRALIZER DISTAL STEM CENTRALIZERDepuy, Inc.1995-07-11
K951934PFC CEMENT RESTRICTORJohnson & Johnson Professionals, Inc.1995-05-16