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, Hip, Cement Restrictor
510(k) Number K032095
Device Name INTERPORE CROSS CEMENT RESTRICTOR
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact PROSIE REY-FESSLER
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact PROSIE REY-FESSLER
Regulation Number878.3300
Classification Product Code
JDK  
Date Received07/08/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-