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 Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K964458
Device Name ELLIS EXTERNAL MINI-FIXATOR SYSTEM
Applicant
Link America, Inc.
3700 S. Tamiami Trail
Sarasota,  FL  34239
Applicant Contact DOUGLAS W STUART
Correspondent
Link America, Inc.
3700 S. Tamiami Trail
Sarasota,  FL  34239
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/07/1996
Decision Date 12/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-