Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K123487 |
Device Name |
GSO GS1 CANNULATED SCREW SYSTEM |
Applicant |
GOLD STANDARD ORTHOPAEDICS, LLC |
1226 ROWAN ST. |
LOUISVILLE,
KY
40203
|
|
Applicant Contact |
DAVID BAUGHMAN |
Correspondent |
GOLD STANDARD ORTHOPAEDICS, LLC |
1226 ROWAN ST. |
LOUISVILLE,
KY
40203
|
|
Correspondent Contact |
DAVID BAUGHMAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/13/2012 |
Decision Date | 03/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|