Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K192006 |
Device Name |
SIRION Lateral Lumbar Interbody System |
Applicant |
Astura Medical, LLC |
3168 Lionshead Ave, Suite 100 |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Parker Kelch |
Correspondent |
Astura Medical, LLC |
3168 Lionshead Ave, Suite 100 |
Carlsbad,
CA
92010
|
|
Correspondent Contact |
Parker Kelch |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/29/2019 |
Decision Date | 04/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|