Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
510(k) Number K940297
Device Name UNIVERSAL WRIST
Applicant
Turnkey Intergration USA, Inc.
6060 Castleway Dr. W.
Suite 236
Indianapolis,  IN  46250
Applicant Contact DOUGLAS W STUART
Correspondent
Turnkey Intergration USA, Inc.
6060 Castleway Dr. W.
Suite 236
Indianapolis,  IN  46250
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3800
Classification Product Code
JWI  
Date Received01/21/1994
Decision Date 02/06/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-