FDA.report

510(k) K993438

Device
METAL ON METAL ACETABULAR SYSTEM
Applicant
BIOMET, INC.
510(k) number
K993438
Product code
KWA  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-18
Date received
1999-10-12
Regulation
888.3330
Classification name
Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MICHELLE L MCKINLEY
Address
Airport Industrial Park P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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
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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