Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K932425 |
Device Name |
FOUNDATION MODULAR TIBIAL BASEPLATE |
Applicant |
ENCORE ORTHOPEDICS, INC. |
8920 BUSINESS PARK DR. |
SUTIE 380 |
AUSTIN,
TX
78759
|
|
Applicant Contact |
J. D WEBB |
Correspondent |
ENCORE ORTHOPEDICS, INC. |
8920 BUSINESS PARK DR. |
SUTIE 380 |
AUSTIN,
TX
78759
|
|
Correspondent Contact |
J. D WEBB |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 05/19/1993 |
Decision Date | 07/22/1994 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|