Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K192121 |
Device Name |
Black Diamond Pedicle Screw System |
Applicant |
Osseus Fusion Systems |
2703 Mockingbird Lane, Suite 102 |
Dallas,
TX
75235
|
|
Applicant Contact |
Robert Pace |
Correspondent |
The OrthoMedix Group, Inc. |
4313 W. 3800 S. |
West Haven,
UT
84401
|
|
Correspondent Contact |
J. D. Webb |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 08/06/2019 |
Decision Date | 10/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|