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 K183025
Device Name MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
Applicant
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Applicant Contact Allison Gecik
Correspondent
B-One Ortho, Corp.
3 Wing Dr., Suite 259
Cedar Knolls,  NJ  07927
Correspondent Contact Allison Gecik
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received11/01/2018
Decision Date 01/28/2019
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
-
-