• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122463
Models CM-2409, CM-2410, CM-2411
Device Name APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
Original Applicant
CAYENNE MEDICAL, INC.
16597 n. 92nd street
suite 101
scottsdale,  AZ  85260
Original Contact kereshmeh shahriari
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/13/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-