Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K122332 |
Device Name |
TOWERLOX PEDICLE SCREW SYSTEM |
Applicant |
CAPTIVA SPINE |
13540 GUILD AVE |
APPLE VALLY,
MN
55124
|
|
Applicant Contact |
RICH JANSEN |
Correspondent |
CAPTIVA SPINE |
13540 GUILD AVE |
APPLE VALLY,
MN
55124
|
|
Correspondent Contact |
RICH JANSEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2012 |
Decision Date | 10/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|