Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K122571 |
Device Name |
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM |
Applicant |
SEASPINE, INC. |
2302 la Mirada Dr |
VISTA,
CA
92081
|
|
Applicant Contact |
ETHEL BERNAL |
Correspondent |
SEASPINE, INC. |
2302 la Mirada Dr |
VISTA,
CA
92081
|
|
Correspondent Contact |
ETHEL BERNAL |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/23/2012 |
Decision Date | 12/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|