Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K050937 |
FOIA Releasable 510(k) |
K050937
|
Device Name |
TRABECULAR METAL ACETABULAR REVISION SHELLS |
Applicant |
ZIMMER TRABECULAR |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
MARCI HALEVI |
Correspondent |
ZIMMER TRABECULAR |
80 COMMERCE DR. |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
MARCI HALEVI |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/14/2005 |
Decision Date | 05/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|