• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, cemented
510(k) Number K964655
Device Name UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
Original Applicant
HOWMEDICA CORP.
359 veterans blvd.
rutherford,  NJ  07070
Original Contact john dichiara
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
JDL   JWH   LPH  
Date Received11/20/1996
Decision Date 02/06/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-