K231834
- 510(k) number
- K231834
- Device name
- VSP PEEK Cranial Implant
- Applicant
- 3D Systems, Inc. CO · US
- Product code
- GWO — Plate, Cranioplasty, Preformed, Alterable
- Decision date
- 2024-04-04
- Date received
- 2023-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K231834.pdf
Official FDA record: K231834
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.