• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name prosthesis, shoulder, non-constrained, metal/polymer cemented
510(k) Number K122692
Device Name ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original Contact anthony francalancia
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Codes
HSD   KWS  
Date Received09/04/2012
Decision Date 12/03/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-