FDA.reportPublic FDA data

510(k) K001471

Device
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
Applicant
IMPLEX CORP.
510(k) number
K001471
Product code
LWJ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-08-07
Date received
2000-05-11
Regulation
888.3360
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN A SCHALAGO
Address
80 Commerce Dr. Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LWJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.2012-10-12
K103518TRINITY ACETABULAR SYSTEMCorin USA2011-03-09
K090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.2009-04-21
K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.2008-09-09
K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.2007-01-31
K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.2007-01-16
K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, Inc.2006-12-21
K061699EXCIAAesculap, Inc.2006-08-18
K051826BETACONE HIP PROSTHESIS SYSTEMWaldemar Link GmbH & Co. KG2005-11-18
K050262U2 ACETABULAR COMPONENTUnited Orthopedic Corp.2005-08-15
K042344EXCIA TOTAL HIP SYSTEMAesculap, Inc.2005-03-16
K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDOsteoimplant Technology, Inc.2005-01-25
K033313QUATRO M FEMORAL COMPONENTWhiteside Biomechanics, Inc.2004-07-28
K032709MODULAR PLUS HIP STEMPlus Orthopedics2003-09-23
K032110PROCLASS PRESS FIT HIP STEMStelkast Company2003-09-22

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases