Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K120419 |
Device Name |
DYNA LOCKING ANKLE NAIL |
Applicant |
U&I CORP. |
20, Sandan-ro 76beon-gil(Rd) |
Uijeongbu-si,
KR
480-859
|
|
Applicant Contact |
GYEONG-JE KWON |
Correspondent |
U&I CORP. |
20, Sandan-ro 76beon-gil(Rd) |
Uijeongbu-si,
KR
480-859
|
|
Correspondent Contact |
GYEONG-JE KWON |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 02/10/2012 |
Decision Date | 05/21/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|