Device Classification Name |
prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
|
510(k) Number |
K113107 |
Device Name |
MSA HIP SYSTEM |
Applicant |
GLOBAL MANUFACTURING TECHNOLOGY |
1331 H STREET NW |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
HOLLACE S RHODES |
Correspondent |
GLOBAL MANUFACTURING TECHNOLOGY |
1331 H STREET NW |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
HOLLACE S RHODES |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/20/2011 |
Decision Date | 12/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|