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FDA 510(k)

VSP Cranial System

K-Number: K151285 · 2016-09-23

Applicant3D Systems, Inc.
Decision Date2016-09-23
Product CodePPT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VSP Cranial System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2016-09-23 under 510(k) number K151285. The device is classified under product code PPT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSP Cranial System?

VSP Cranial System is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is 3D Systems, Inc.. The 510(k) number is K151285.

When did VSP Cranial System receive FDA 510(k) clearance?

VSP Cranial System received FDA 510(k) clearance on 2016-09-23, under 510(k) number K151285.

Who is the listed applicant for VSP Cranial System?

The FDA 510(k) record lists 3D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSP Cranial System?

The FDA product code for VSP Cranial System is PPT.

Other records listing 3D Systems, Inc. as applicant

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Related Devices (Code: PPT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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