Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K121615 |
Device Name |
4CIS VANE SPINE SYSTEM |
Applicant |
SOLCO BIOMEDICAL CO., LTD. |
9700 GREAT SENECA HIGHWAY |
STE 302 |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
SAEYOUNG AHN |
Correspondent |
SOLCO BIOMEDICAL CO., LTD. |
9700 GREAT SENECA HIGHWAY |
STE 302 |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
SAEYOUNG AHN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/01/2012 |
Decision Date | 08/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|