Device Classification Name |
prosthesis, hip, semi-constrained (metal uncemented acetabular component)
|
510(k) Number |
K843950 |
Device Name |
LINK CEMENTLESS SCREW-IN ACETABULAR CUP |
Applicant |
WALDEMAR LINK GMBH & CO. KG |
10 GREAT MEADOW LN. |
E. HANOVER,
NJ
07936
|
|
Applicant Contact |
ED SCHUSSLER |
Correspondent |
WALDEMAR LINK GMBH & CO. KG |
10 GREAT MEADOW LN. |
E. HANOVER,
NJ
07936
|
|
Correspondent Contact |
ED SCHUSSLER |
Regulation Number | 888.3330
|
Classification Product Code |
|
Date Received | 10/09/1984 |
Decision Date | 06/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|