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, Spinal Pedicle Fixation
510(k) Number K073240
Device Name PSS SYSTEM
Applicant
Spinal USA
644 Lakeland E. Dr., Suite A
Flowood,  MS  39232
Applicant Contact JEFFREY JOHNSON
Correspondent
Spinal USA
644 Lakeland E. Dr., Suite A
Flowood,  MS  39232
Correspondent Contact JEFFREY JOHNSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received11/16/2007
Decision Date 03/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-