Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K133152 |
Device Name |
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT |
Applicant |
STANMORE IMPLANTS WORLDWIDE LTD. |
555 THIRTEENTH ST, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
GERARD J PRUD'HOMME |
Correspondent |
STANMORE IMPLANTS WORLDWIDE LTD. |
555 THIRTEENTH ST, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
GERARD J PRUD'HOMME |
Regulation Number | 888.3510
|
Classification Product Code |
|
Date Received | 11/22/2013 |
Decision Date | 01/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|