Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K181347 |
Device Name |
Aries® Lumbar Interbodies |
Applicant |
Osseus Fusion Systems, LLC |
2703 Mockingbird Lane, Suite 102 |
Dallas,
TX
75235
|
|
Applicant Contact |
Robert Pace |
Correspondent |
The OrthoMedix Group, Inc. |
1001 Oakwood Blvd |
Round Rock,
TX
78681
|
|
Correspondent Contact |
J. D. Webb |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/21/2018 |
Decision Date | 08/15/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|