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 K170753
Device Name Acculoc Total Knee System
Applicant
Rootloc Co., Ltd.
#1210, 68, Digital-Ro 9-Gil
Geumcheon-Gu,  KR 08512
Applicant Contact Jungsun Ha
Correspondent
Rootloc Co., Ltd.
#1210, 68, Digital-Ro 9-Gil
Geumcheon-Gu,  KR 08512
Correspondent Contact Jungsun Ha
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/13/2017
Decision Date 03/23/2018
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
-
-