Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K970031 |
Device Name |
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT |
Applicant |
ENCORE ORTHOPEDICS, INC. |
8900 SHOAL CREEK BLVD., |
BLDG. 300 |
AUSTIN,
TX
78757
|
|
Applicant Contact |
ASHLEY M BOCK |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
8900 SHOAL CREEK BLVD., |
BLDG. 300 |
AUSTIN,
TX
78757
|
|
Correspondent Contact |
ASHLEY M BOCK |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/03/1997 |
Decision Date | 04/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|