Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K192396 |
Device Name |
Streamline MIS Spinal Fixation System |
Applicant |
Pioneer Surgical Technology, Inc. |
(DBA RTI Surgical Inc.) |
375 River Park Circle |
Marquette,
MI
49855
|
|
Applicant Contact |
Michael Mach |
Correspondent |
Pioneer Surgical Technology, Inc. |
(DBA RTI Surgical Inc.) |
375 River Park Circle |
Marquette,
MI
49855
|
|
Correspondent Contact |
Michael Mach |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 09/03/2019 |
Decision Date | 11/26/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|