Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K121725 |
Device Name |
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM |
Applicant |
PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE |
MARQUETTE,
MI
49855
|
|
Applicant Contact |
SARAH MCINTYRE |
Correspondent |
PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE |
MARQUETTE,
MI
49855
|
|
Correspondent Contact |
SARAH MCINTYRE |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/12/2012 |
Decision Date | 11/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|