FDA.report

510(k) K111698

Device
PROFEMUR(R) E CEMENTLESS HIP STEM
Applicant
Wrightmedicaltechnologyinc
510(k) number
K111698
Product code
KWA
Decision
Substantially Equivalent (SESE)
Decision date
2011-08-19
Date received
2011-06-17
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
N

Related Records

Applicant Contact

Contact
GREGORY NEAL
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)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
K110399GLADIATOR PLASMA CLASSIC HIP STEMWrightmedicaltechnologyinc2011-05-10
K110029CONSERVE BIO FOAM SHELLWrightmedicaltechnologyinc2011-04-19
K103755TAPERLOC COMPLETE, SIZE 5 AND 6Biomet Manufacturing Corp2011-01-21
K102565ANTERIOR APPROACH HIP SURGERY INSTRUMENTSWrightmedicaltechnologyinc2010-12-22