Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K923443 |
Device Name |
NATURAL-KNEE ALL-POLY TIBIA |
Applicant |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Applicant Contact |
JOANN RINGWE |
Correspondent |
INTERMEDICS ORTHOPEDICS |
1300 EAST ANDERSON LN. |
BUILDING C |
AUSTIN,
TX
78752
|
|
Correspondent Contact |
JOANN RINGWE |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 07/13/1992 |
Decision Date | 03/31/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|