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 K131409
Device Name CAS PSI KNEE SYSTEM
Applicant
ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC,  CA H3C 2N6
Applicant Contact CHRISTOPHER MCLEAN
Correspondent
ORTHOSOFT, INC.
75 QUEEN ST., SUITE 3300
MONTREAL, QUEBEC,  CA H3C 2N6
Correspondent Contact CHRISTOPHER MCLEAN
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OOG  
Date Received05/15/2013
Decision Date 09/13/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-