Device Classification Name |
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
|
510(k) Number |
K852351 |
Device Name |
KIRSCHNER SELF-TAPPING 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 | 888.3330
|
Classification Product Code |
|
Date Received | 05/31/1985 |
Decision Date | 08/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|