Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K963101 |
Device Name |
B-P HEMISPHERICAL ACETABULAR COMPONENT |
Applicant |
ENDOTEC, INC. |
20 VALLEY ST. |
SOUTH ORANGE,
NJ
07079
|
|
Applicant Contact |
MICHAEL PAPPAS, PH.D., PE |
Correspondent |
ENDOTEC, INC. |
20 VALLEY ST. |
SOUTH ORANGE,
NJ
07079
|
|
Correspondent Contact |
MICHAEL PAPPAS, PH.D., PE |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/09/1996 |
Decision Date | 02/12/1997 |
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
|
|
|