Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K011288 |
Device Name |
TC-PLUS POROUS TIBIAL COMPONENTS |
Applicant |
PLUS ORTHOPEDICS |
6055 LUSK BLVD. |
SAN DIEGO,
CA
92121 -2700
|
|
Applicant Contact |
HARTMUT LOCH |
Correspondent |
PLUS ORTHOPEDICS |
6055 LUSK BLVD. |
SAN DIEGO,
CA
92121 -2700
|
|
Correspondent Contact |
HARTMUT LOCH |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 04/27/2001 |
Decision Date | 05/24/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|