• 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 K960279
Device Name NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
Applicant
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact ruth ann wood
Correspondent
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact ruth ann wood
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/19/1996
Decision Date 04/26/1996
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
-
-