Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K123476 |
Device Name |
MEGA 5.5 SPINE SYSTEM |
Applicant |
LSK BIOPARTNERS, INC. |
8 EAST BROADWAY, STE 611 |
SALT LAKE CITY,
UT
84111
|
|
Applicant Contact |
SHIN KUK YOO |
Correspondent |
LSK BIOPARTNERS, INC. |
8 EAST BROADWAY, STE 611 |
SALT LAKE CITY,
UT
84111
|
|
Correspondent Contact |
SHIN KUK YOO |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/13/2012 |
Decision Date | 01/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|