FDA.reportPublic FDA data

510(k) K021799

Device
CEMENTED FEMORAL HEAD RESURFING DEVICE
Applicant
BIOMET ORTHOPEDICS, INC.
510(k) number
K021799
Product code
KXA  
Decision
Substantially Equivalent (SESE)
Decision date
2002-06-26
Date received
2002-05-31
Regulation
888.3400
Classification name
Prosthesis, Hip, Femoral, Resurfacing
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PATRICIA SANDBORN BERES
Address
P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201219Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC2021-01-19
K092198CORMET CEMENTLESS RESURFACING FEMORAL HEADCorin USA2010-04-15
K082673CONSERVE PRESSFIT FEMORAL COMPONENTWrightmedicaltechnologyinc2008-12-12
K071053RECAP HA PRESS-FIT FEMORAL RESURFACING HEADBiomet, Inc.2007-06-29
K070292DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTSZimmer GmbH2007-04-26
K062960CONSERVE FEMORAL RESURFACING COMPONENTWrightmedicaltechnologyinc2006-12-01
K043542BIOPRO TARA FEMORAL RESURFACING COMPONENTBiopro, Inc.2005-05-18
K032659DEPUY ASR RESURFACING FEMORAL HEADSDePuy Orthopaedics, Inc.2003-12-04
K023188PRESS-FIT HEAD RESURFACING DEVICEBiomet Orthopedics, Inc.2002-12-11
K021549CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEMStd Mfg., Inc.2002-08-01
K994153CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESISCorin USA2000-02-25
K983452NELSON RESURFACING HEADBiomet, Inc.1998-12-03
K950998MODUILAR UNIPOLARIntermedics Orthopedics1995-04-13
K944752ORTHOMET RESURFACING FEMORAL COMPONENTOrthomet, Inc.1994-12-28
K904870MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONEndotec, Inc.1991-05-23

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