Device Classification Name |
prosthesis, hip, semi-constrained (metal cemented acetabular component)
|
510(k) Number |
K870867 |
Device Name |
KM-4(TM) METAL-BACKED ACETABULAR CUP |
Applicant |
KIRSCHNER MEDICAL CORP. |
9690 DEERECO ROADD |
TIMONIUM,
MD
21093
|
|
Applicant Contact |
SAM SON |
Correspondent |
KIRSCHNER MEDICAL CORP. |
9690 DEERECO ROADD |
TIMONIUM,
MD
21093
|
|
Correspondent Contact |
SAM SON |
Regulation Number | 888.3320
|
Classification Product Code |
|
Date Received | 03/03/1987 |
Decision Date | 05/08/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|