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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K080229
Device Name 5.5 MM SUTURE LOCK BONE SCREW ANCHOR
Applicant
Kfx Medical
5845 Avenida Encinas,Suite 130
Carlsbad,  CA  92008
Applicant Contact GAYLE HIROTA
Correspondent
Kfx Medical
5845 Avenida Encinas,Suite 130
Carlsbad,  CA  92008
Correspondent Contact GAYLE HIROTA
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received01/30/2008
Decision Date 02/29/2008
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
-
-