Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K971681 |
Device Name |
SMC FEMORAL HIP COMPONENT |
Applicant |
SIGNAL MEDICAL CORP. |
3315 BERRY DR. |
LAKEPORT,
MI
48059
|
|
Applicant Contact |
LOUIS A SERAFIN |
Correspondent |
SIGNAL MEDICAL CORP. |
3315 BERRY DR. |
LAKEPORT,
MI
48059
|
|
Correspondent Contact |
LOUIS A SERAFIN |
Regulation Number | 888.3350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/06/1997 |
Decision Date | 12/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|