FDA.reportPublic FDA data

510(k) K853524

Device
APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
Applicant
INTERMEDICS ORTHOPEDICS
510(k) number
K853524
Product code
KMC  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1985-11-22
Date received
1985-08-22
Regulation
888.3340
Classification name
Prosthesis, Hip, Semi-constrained, Composite/metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS L CRAIG
Address
1300 E. Anderson Ln. Bldg. C Austin TX US 78752 78752

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K936044ENHANCED MODULAR AUSTIN MOORE HIPZimmer, Inc.1994-04-26
K853259MALLORY/HEAD TOTAL HIP SYSTEMBiomet, Inc.1985-11-01

Legacy Summary#

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

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