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/Polymer, Porous Uncemented
510(k) Number K973714
Device Name VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
Applicant
ZIMMER, INC.
508 & 727 NORTH DETROIT ST.
WARSAW,  IN  46580
Applicant Contact KAREN CAIN
Correspondent
ZIMMER, INC.
508 & 727 NORTH DETROIT ST.
WARSAW,  IN  46580
Correspondent Contact KAREN CAIN
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received09/29/1997
Decision Date 12/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-