Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K912663 |
Device Name |
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT |
Applicant |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Applicant Contact |
WEBB |
Correspondent |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
WEBB |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/18/1991 |
Decision Date | 09/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|