Device Classification Name |
mesh, surgical, acetabular, hip, prosthesis
|
510(k) Number |
K972760 |
Device Name |
LINK, ACETABULAR REVISION MESH CUP |
Applicant |
LINK AMERICA, INC. |
321 PALMER RD. |
DENVILLE,
NJ
07834
|
|
Applicant Contact |
DOUGLAS W STUART |
Correspondent |
LINK AMERICA, INC. |
321 PALMER RD. |
DENVILLE,
NJ
07834
|
|
Correspondent Contact |
DOUGLAS W STUART |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/24/1997 |
Decision Date | 10/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|