Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
510(k) Number |
K073499 |
Device Name |
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
ERIC S PITTMAN |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
ERIC S PITTMAN |
Regulation Number | 888.3320
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/13/2007 |
Decision Date | 08/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|