VSP Cranial System
FDA 510(k) K151285 · 3D Systems, Inc.
510(k) numberK151285
Submission
- Device name
- VSP Cranial System
- Applicant
- 3D Systems, Inc.
Golden, CO, US - Received
- May 14, 2015
- Decision date
- September 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPT – Cranial Surgical Planning And Instrument Guides
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4310
- Specialty
- Neurology
Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Other 510(k)s with product code PPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253308 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…PPT · Special | Materialise NV | 01/07/2026SE |
| K201052 | KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT · Traditional | KLS-Martin L.P. | 08/31/2020SE |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning SystemPPT · Traditional | KLS-Martin L.P. | 07/26/2019SE |
More from KLS-Martin L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 06/03/2026SE |
| K250711 | VSP Orthopedics SystemPBF · Traditional | 12/05/2025SE |
| K243174 | Cadence Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 04/04/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
Questions and answers
When was VSP Cranial System cleared by the FDA?
VSP Cranial System (K151285) received a 510(k) decision of Substantially Equivalent on September 23, 2016, 498 days after the submission was received.
What is the product code of K151285?
The FDA product code is PPT – Cranial Surgical Planning And Instrument Guides, a Class II (moderate risk) device regulated under 21 CFR 882.4310.