Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K240126 |
Device Name |
ProAM ALIF System |
Applicant |
Pro Surgical, Inc. |
3875 Copper Crest Rd. |
Encinitas,
CA
92024
|
|
Applicant Contact |
Blain Jason |
Correspondent |
Pro Surgical, Inc. |
3875 Copper Crest Rd. |
Encinitas,
CA
92024
|
|
Correspondent Contact |
Jason Blain |
Regulation Number | 888.3080 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/16/2024 |
Decision Date | 05/03/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|