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 K033512
Device Name PROCYON SPINAL SYSTEM
Applicant
Nas Medical Technologies, Inc.
9191 Towne Centre Dr.
Suite 395
San Diego,  CA  92122
Applicant Contact MAKOTO NONAKA
Correspondent
Nas Medical Technologies, Inc.
9191 Towne Centre Dr.
Suite 395
San Diego,  CA  92122
Correspondent Contact MAKOTO NONAKA
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received11/06/2003
Decision Date 06/03/2004
Decision Substantially Equivalent (SESE)
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
-
-