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 K240324
Device Name EMPOWR Revision Symmetric Knee Cones
Applicant
Encore Medical, L.P. (dba Enovis)
9800 Metric Boulevard
Austin,  TX  78758
Applicant Contact Trey Thorsen
Correspondent
Encore Medical, L.P. (dba Enovis)
9800 Metric Boulevard
Austin,  TX  78758
Correspondent Contact Trey Thorsen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
MBH  
Date Received02/02/2024
Decision Date 04/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-