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 K934166
Device Name NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION
Applicant
Corin Orthopedic Products
10500 University Center Dr.
Suite 130
Tampa,  FL  33612
Applicant Contact JACK THOMAS
Correspondent
Corin Orthopedic Products
10500 University Center Dr.
Suite 130
Tampa,  FL  33612
Correspondent Contact JACK THOMAS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/27/1993
Decision Date 09/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-