Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K012702 |
Device Name |
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 |
Applicant |
ENDOTEC, INC. |
20 VALLEY ST. |
SOUTH ORANGE,
NJ
07079
|
|
Applicant Contact |
ALEX CANONACO |
Correspondent |
ENDOTEC, INC. |
20 VALLEY ST. |
SOUTH ORANGE,
NJ
07079
|
|
Correspondent Contact |
ALEX CANONACO |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 08/14/2001 |
Decision Date | 01/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|