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 Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K160484
Device Name Optetrak Advanced Patella
Applicant
EXACTECH INC
2320 NW 66TH CT
GAINESVILLE,  FL  32653
Applicant Contact PATRICK HUGHES
Correspondent
EXACTECH INC
2320 NW 66TH CT
GAINESVILLE,  FL  32653
Correspondent Contact PATRICK HUGHES
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/22/2016
Decision Date 03/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-