Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K211873 |
Device Name |
PSX Interbody System |
Applicant |
Alphatec Spine, Inc. |
1950 Camino Vida Roble |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Cynthia Dorne |
Correspondent |
Alphatec Spine, Inc. |
1950 Camino Vida Roble |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Cynthia Dorne |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/17/2021 |
Decision Date | 08/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|