Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K023528 |
Device Name |
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE |
Applicant |
CENTERPLUS ORTHOPEDICS, INC |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
MITCHELL A DHORITY |
Correspondent |
CENTERPLUS ORTHOPEDICS, INC |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
MITCHELL A DHORITY |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 10/21/2002 |
Decision Date | 01/17/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|