Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K121636 |
Device Name |
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT |
Applicant |
TGM MEDICAL, INC. |
5145 Golden Foothill Parkway |
SUITE 175 |
El Dorado Hills,
CA
95762
|
|
Applicant Contact |
PRAKASH PAI |
Correspondent |
TGM MEDICAL, INC. |
5145 Golden Foothill Parkway |
SUITE 175 |
El Dorado Hills,
CA
95762
|
|
Correspondent Contact |
PRAKASH PAI |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|