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 K192428
Device Name AFX Femoral Implant with Inserter
Applicant
Cayenne Medical
16597 N 92nd St.
Scottsdale,  AZ  85260
Applicant Contact Shima Hashemian
Correspondent
Cayenne Medical
16597 N 92nd St.
Scottsdale,  AZ  85260
Correspondent Contact Shima Hashemian
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/05/2019
Decision Date 10/05/2019
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
-
-