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 screw, fixation, bone
510(k) Number K063070
Device Name APERFIX TIBIAL IMPLANT WITH INSERTER
Applicant
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact floyd larson
Correspondent
CAYENNE MEDICAL, INC.
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact floyd larson
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/06/2006
Decision Date 12/14/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-