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510(k) K031963

Device
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
510(k) number
K031963
Product code
KWA  
Decision
Substantially Equivalent (SESE)
Decision date
2003-10-31
Date received
2003-06-25
Regulation
888.3330
Classification name
Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
3
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATIE LOGEROT
Address
5677 Airline Rd. Arlington TN US 38002 38002

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
K111699PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEMWrightmedicaltechnologyinc2011-08-19
K111698PROFEMUR(R) E CEMENTLESS 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#

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