Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K192248 |
Device Name |
Cortina™ [MAX] Lumbar Cage System |
Applicant |
NeuroStructures, Inc. |
199 Technology Drive, Suite 110 |
Irvine,
CA
92618
|
|
Applicant Contact |
Moti Altarac |
Correspondent |
Empirical Testing Corp. |
4628 Northpark Drive |
Colorado Springs,
CO
80918
|
|
Correspondent Contact |
Meredith Lee May |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 11/25/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|