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510(k) K940297

Device
UNIVERSAL WRIST
Applicant
TURNKEY INTERGRATION USA, INC.
510(k) number
K940297
Product code
JWI  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-02-06
Date received
1994-01-21
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
DOUGLAS W STUART
Address
6060 Castleway Dr. W. Suite 236 Indianapolis IN US 46250 46250

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
K931265FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2NDFerguson Medical1995-05-22
K792687ASPERGILLUS SP., ANTIGENMeridian Diagnostics, Inc.1980-01-17

Legacy Summary#

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FDA Review#

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