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, semi-constrained (metal uncemented acetabular component)
510(k) Number K102080
Device Name DEPUY RECLAIM REVISION HIP SYSTEM
Applicant
DEPUY (IRELAND)
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
DePuy Synthes
3 Main Street
Ringaskiddy,  IE
Correspondent Contact Jennifer Hill
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Code
LZO  
Date Received07/26/2010
Decision Date 11/23/2010
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
-
-