VSP Cranial System— 510(k) K151285

Substantially Equivalent

3D Systems, Inc.

FDA 510(k) clearance K151285 for VSP Cranial System, Substantially Equivalent on 2016-09-23. Applicant: 3D Systems, Inc.. Device class: 2.

Clearance details

Applicant: 3D Systems, Inc.
Product code: Code PPT
Device class: Class 2
Regulation: 21 CFR 882.4310
Advisory panel: Neurology
Date received: 2015-05-14
Decision date: 2016-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PPT

More clearances from 3D Systems, Inc.

K261826 — VSP System (Titanium Palatal Splint)2026-06-03
K250711 — VSP Orthopedics System2025-12-05
K243173 — Salto Talaris Ankle PSI System2024-10-25
K243174 — Cadence Ankle PSI System2024-10-25
K241148 — Salto Talaris Ankle PSI System2024-08-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.