Device Classification Name |
prosthesis, hip, constrained, cemented or uncemented, metal/polymer
|
510(k) Number |
K071718 |
Device Name |
TRILOGY LONGEVITY CONSTRAINED LINER |
Applicant |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Applicant Contact |
STEPHEN MCKELVEY |
Correspondent |
ZIMMER, INC. |
P.O. BOX 708 |
WARSAW,
IN
46581 -0708
|
|
Correspondent Contact |
STEPHEN MCKELVEY |
Regulation Number | 888.3310
|
Classification Product Code |
|
Date Received | 06/22/2007 |
Decision Date | 07/13/2007 |
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
|
|
|