Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K133690 |
Device Name |
TRUE SPINAL FUSSION SYSTEM |
Applicant |
INNOVATIVE SURGICAL DESIGNS |
2660 E. 2ND STREET #10 |
BLOOMINGTON,
IN
47401
|
|
Applicant Contact |
ED MORRIS |
Correspondent |
INNOVATIVE SURGICAL DESIGNS |
2660 E. 2ND STREET #10 |
BLOOMINGTON,
IN
47401
|
|
Correspondent Contact |
ED MORRIS |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2013 |
Decision Date | 05/07/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|