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, Spinal Interlaminal
510(k) Number K896740
Device Name AXIAL AND OFFSET CROSSLINK PLATES
Applicant
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Applicant Contact FRANK M LEWIS
Correspondent
Danek Medical, Inc.
3092 Director'S Row
Memphis,  TN  38131
Correspondent Contact FRANK M LEWIS
Regulation Number888.3050
Classification Product Code
KWP  
Date Received11/30/1989
Decision Date 02/26/1990
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
-
-