Device Classification Name |
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K121029 |
Device Name |
METS MODULAR DISTAL FEMUR |
Applicant |
STANMORE IMPLANTS WORLDWIDE LTD |
690 CANTON STREET |
SUITE 302 |
WESTWOOD,
MA
02090
|
|
Applicant Contact |
NANCY C MACDONALD |
Correspondent |
STANMORE IMPLANTS WORLDWIDE LTD |
690 CANTON STREET |
SUITE 302 |
WESTWOOD,
MA
02090
|
|
Correspondent Contact |
NANCY C MACDONALD |
Regulation Number | 888.3510
|
Classification Product Code |
|
Date Received | 04/05/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|