• 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 K230169
Device Name EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
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
OIY  
Date Received01/20/2023
Decision Date 04/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-