Device Classification Name |
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
|
510(k) Number |
K842518 |
Device Name |
UNILOC-CEMENTLESS & SELF TAP ACETABULAR |
Applicant |
AMERICAN ORTOMED CORP. |
P.O. BOX 3184 |
72 BEECHWOOD AVENUE |
POUGHKEEPSIE,
NY
12603
|
|
Applicant Contact |
MICHAEL M STEK |
Correspondent |
AMERICAN ORTOMED CORP. |
P.O. BOX 3184 |
72 BEECHWOOD AVENUE |
POUGHKEEPSIE,
NY
12603
|
|
Correspondent Contact |
MICHAEL M STEK |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 07/10/1984 |
Decision Date | 01/30/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|