Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K902111 |
Device Name |
MODIFIED FREEMAN REVISION ACETABULAR CUP |
Applicant |
TURNKEY INTERGRATION USA, INC. |
8021 KNUE RD. |
SUITE 121 |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
DOUGLAS W STUART |
Correspondent |
TURNKEY INTERGRATION USA, INC. |
8021 KNUE RD. |
SUITE 121 |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
DOUGLAS W STUART |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 05/09/1990 |
Decision Date | 08/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|