Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K121312 |
Device Name |
INTRAMEDULLARY NAIL SYSTEM |
Applicant |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
PO BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Applicant Contact |
Diana Hong |
Correspondent |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
PO BOX 237-023 |
SHANGHAI,
CN
200237
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 05/01/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|