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 K930657
Device Name D-C-S SYSTEM
Applicant
Pina-Vertriebs
Engestrasse 35 Ch-8212
Neuhausen 2/Sh
Switzerland,  CH
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Pina-Vertriebs
Engestrasse 35 Ch-8212
Neuhausen 2/Sh
Switzerland,  CH
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received02/09/1993
Decision Date 06/29/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-