Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K180179 |
Device Name |
Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw |
Applicant |
Orthofix Inc. |
3451 Plano Parkway |
Lewisville,
TX
75056
|
|
Applicant Contact |
Jacki Koch |
Correspondent |
Orthofix Inc. |
3451 Plano Parkway |
Lewisville,
TX
75056
|
|
Correspondent Contact |
Jacki Koch |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 01/23/2018 |
Decision Date | 08/24/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|