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 Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K953635
Device Name TITANIUM DYNA-LOK SPINAL SYSTEM
Applicant
Sofamor Danek USA,Inc.
100 Publishers Dr.
Winona Lake,  IN  46590
Applicant Contact RICHARD W TREHARNE
Correspondent
Sofamor Danek USA,Inc.
100 Publishers Dr.
Winona Lake,  IN  46590
Correspondent Contact RICHARD W TREHARNE
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received08/02/1995
Decision Date 10/30/1995
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
-
-