• 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, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K123019
Device Name LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
Applicant
ZIMMER, INC.
1800 WEST CENTER STREET
warsaw,  IN  46580
Applicant Contact rebecca brooks
Correspondent
ZIMMER, INC.
1800 WEST CENTER STREET
warsaw,  IN  46580
Correspondent Contact rebecca brooks
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received09/28/2012
Decision Date 10/22/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-