Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K130286 |
Device Name |
STREAMLINE MIS SPINAL FIXATION SYSTEM |
Applicant |
PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE |
MARQUETTE,
MI
49855
|
|
Applicant Contact |
EMILY M DOWNS |
Correspondent |
PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE |
MARQUETTE,
MI
49855
|
|
Correspondent Contact |
EMILY M DOWNS |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/05/2013 |
Decision Date | 04/01/2013 |
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
|
|
|