Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K153428 |
Device Name |
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System |
Applicant |
ORTHOFIX INC. |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Applicant Contact |
Jacki Geren |
Correspondent |
ORTHOFIX INC. |
3451 PLANO PARKWAY |
LEWISVILLE,
TX
75056
|
|
Correspondent Contact |
Jacki Geren |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/25/2015 |
Decision Date | 01/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|