Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K883969 |
Device Name |
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM |
Applicant |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Applicant Contact |
THOMAS L CRAIG |
Correspondent |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
THOMAS L CRAIG |
Regulation Number | 888.3530
|
Classification Product Code |
|
Date Received | 09/20/1988 |
Decision Date | 04/19/1989 |
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
|
|
|