Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K941306 |
Device Name |
FOUNDATION KNEE AUGMENTATION BLOCKS |
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 | 03/17/1994 |
Decision Date | 02/08/1995 |
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
|
|
|