Device Classification Name |
plate, cranioplasty, preformed, alterable
|
510(k) Number |
K231834 |
Device Name |
VSP PEEK Cranial Implant |
Applicant |
3D Systems, Inc. |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Applicant Contact |
Ashley Dawson |
Correspondent |
3D Systems, Inc. |
5381 South Alkire Circle |
Littleton,
CO
80127
|
|
Correspondent Contact |
Ashley Dawson |
Regulation Number | 882.5320
|
Classification Product Code |
|
Date Received | 06/22/2023 |
Decision Date | 04/04/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|