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
510(k) Number K943277
Device Name LINK SADDLE PROTHESIS
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
Date Received07/07/1994
Decision Date 01/26/1995
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-