Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K221221 |
Device Name |
Advanced Intramedullary Nail System |
Applicant |
Double Medical Technology Inc. |
No.18, Shanbianhong East Road, Haicang District |
Xiamen,
CN
361026
|
|
Applicant Contact |
Yan Zuo |
Correspondent |
Double Medical Technology Inc. |
No.18, Shanbianhong East Road, Haicang District |
Xiamen,
CN
361026
|
|
Correspondent Contact |
Yan Zuo |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 04/27/2022 |
Decision Date | 12/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|