Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
|
510(k) Number |
K960425 |
Device Name |
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX |
Applicant |
ENDOTEC, INC. |
111 ORANGE ST. |
BLOOMFIELD,
NJ
07003
|
|
Applicant Contact |
GEORGE MAKRIS,MSME |
Correspondent |
ENDOTEC, INC. |
111 ORANGE ST. |
BLOOMFIELD,
NJ
07003
|
|
Correspondent Contact |
GEORGE MAKRIS,MSME |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 10/03/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|