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 Light, Surgical, Fiberoptic
510(k) Number K082992
Device Name AXXION LIGHT GUIDE
Applicant
SPINAL ELEMENTS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD,  CA  92010
Applicant Contact KERRI DIMARTINO
Correspondent
SPINAL ELEMENTS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD,  CA  92010
Correspondent Contact KERRI DIMARTINO
Regulation Number878.4580
Classification Product Code
FST  
Date Received10/07/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-