• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name prosthesis, hip, semi-constrained (metal uncemented acetabular component)
510(k) Number K071723
Device Name ZIMMER POROLOCK MIS STEM
Original Applicant
ZIMMER GMBH
p.o. box 708
warsaw,  IN  46581 -0708
Original Contact dalene t binkley
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWL   KWY   KWZ  
LWJ   LZO  
Date Received06/25/2007
Decision Date 03/07/2008
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
-
-