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 K243295
Device Name Initia Knee System
Applicant
Kyocera Medical Technologies, Inc.
1289 Bryn Mawr Ave., Suite A.
Redlands,  CA  92374
Applicant Contact DeBenedictis Anthony
Correspondent
Swearingen Regulatory Consulting, LLC
16856 Cir. Hill Dr.
Dexter,  MO  63841
Correspondent Contact Audrey Swearingen
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received10/18/2024
Decision Date 01/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-