Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
510(k) Number |
K915529 |
Device Name |
FPC/SFPC/RFPC ACETABULAR COMPONENT |
Applicant |
IMPLANTOLOGY CORP. |
11 OAK LN. |
PINE BROOK,
NJ
07058
|
|
Applicant Contact |
MARK R FORTE |
Correspondent |
IMPLANTOLOGY CORP. |
11 OAK LN. |
PINE BROOK,
NJ
07058
|
|
Correspondent Contact |
MARK R FORTE |
Regulation Number | 888.3320
|
Classification Product Code |
|
Date Received | 12/10/1991 |
Decision Date | 07/13/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|