FDA.reportPublic FDA data

510(k) K931265

Device
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
Applicant
FERGUSON MEDICAL
510(k) number
K931265
Product code
JWI  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-05-22
Date received
1993-03-08
Regulation
888.3800
Classification name
Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANK FERGUSON
Address
3407 Bay Ave. Chico CA US 95973 95973

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JWI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940297UNIVERSAL WRISTTurnkey Intergration USA, Inc.1995-02-06
K792687ASPERGILLUS SP., ANTIGENMeridian Diagnostics, Inc.1980-01-17

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