Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
|
510(k) Number |
K113556 |
Device Name |
WAGNER CONE PROSTHESIS SYSTEM |
Applicant |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
DANIEL J WILLIAM |
Correspondent |
ZIMMER GMBH |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
DANIEL J WILLIAM |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/01/2011 |
Decision Date | 02/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|