Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K050471 |
Device Name |
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM |
Applicant |
SOLCO BIOMEDICAL CO., LTD. |
7612 BARNUM ROAD |
BETHESDA,
MD
20817
|
|
Applicant Contact |
SAEYOUNG AHN |
Correspondent |
SOLCO BIOMEDICAL CO., LTD. |
7612 BARNUM ROAD |
BETHESDA,
MD
20817
|
|
Correspondent Contact |
SAEYOUNG AHN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/2005 |
Decision Date | 05/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|