FDA.reportPublic FDA data

510(k) K082239

Device
DEPUY C-STEM AMT
Applicant
DEPUY ORTHOPAEDICS, INC.
510(k) number
K082239
Product code
KWA  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-29
Date received
2008-08-07
Regulation
888.3330
Classification name
Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RHONDA MYER
Address
700 Orthopaedic Dr. Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyinc2012-10-11
K121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc2012-07-30
K113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.2012-05-18
K113322CONSERVE THIN SHELLWrightmedicaltechnologyinc2012-02-03
K112080PRESERVE HIP STEMWrightmedicaltechnologyinc2011-12-28
K112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc2011-11-23
K113019PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZERWrightmedicaltechnologyinc2011-11-10
K111910GLADIATOR HIP STEMWrightmedicaltechnologyinc2011-10-14
K110836CLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbH2011-10-07
K110400TAPERLOC COMPLETE MICROPLASTY STEMBiomet Manufacturing Corp2011-09-30
K111698PROFEMUR(R) E CEMENTLESS HIP STEMWrightmedicaltechnologyinc2011-08-19
K111699PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEMWrightmedicaltechnologyinc2011-08-19
K110399GLADIATOR PLASMA CLASSIC HIP STEMWrightmedicaltechnologyinc2011-05-10
K110029CONSERVE BIO FOAM SHELLWrightmedicaltechnologyinc2011-04-19
K103755TAPERLOC COMPLETE, SIZE 5 AND 6Biomet Manufacturing Corp2011-01-21

Legacy Summary#

summary

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