Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K153525 |
Device Name |
Seneka II Polyscrew Pedicle Fixation System |
Applicant |
Senecka Spine |
46 Harrison Street |
Johnson City,
NY
13790
|
|
Applicant Contact |
Khalid Sethi |
Correspondent |
SILVER PINE CONSULTING, LLC. |
11821 BRAMBLE COVE DRIVE |
Fort Myers,
FL
33905
|
|
Correspondent Contact |
Rich Jansen |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/09/2015 |
Decision Date | 01/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|