Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K222554 |
Device Name |
EL CAPITAN Anterior Lumbar Interbody Fusion |
Applicant |
Astura Medical |
4949 W Royal Ln. |
Irving,
TX
75063
|
|
Applicant Contact |
Parker Kelch |
Correspondent |
Astura Medical |
4949 W Royal Ln. |
Irving,
TX
75063
|
|
Correspondent Contact |
Parker Kelch |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 08/23/2022 |
Decision Date | 01/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|