Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K152259 |
Device Name |
InFill Interbody Fusion Device |
Applicant |
Pinnacle Spine Group, LLC |
1601 Elm Street |
Suite 1930 |
Dallas,
TX
75201
|
|
Applicant Contact |
Rebecca K Pine |
Correspondent |
Pinnacle Spine Group, LLC |
1601 Elm Street |
Suite 1930 |
Dallas,
TX
75201
|
|
Correspondent Contact |
Rebecca K Pine |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/11/2015 |
Decision Date | 11/19/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|