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, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K062029
Device Name ANATOMICAL SHOULDER FRACTURE SYSTEM
Applicant
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact MASON W ROBBINS
Correspondent
ZIMMER GMBH
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact MASON W ROBBINS
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received07/18/2006
Decision Date 10/31/2006
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
-
-