Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K121176 |
Device Name |
STGC |
Applicant |
CARDINAL SPINE, LLC |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
9213
|
|
Applicant Contact |
KEVIN A THOMAS |
Correspondent |
CARDINAL SPINE, LLC |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
9213
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 04/18/2012 |
Decision Date | 08/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|