VSP PEEK Cranial Implant
K-Number: K231834 · 2024-04-04
Applicant3D Systems, Inc.
Decision Date2024-04-04
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VSP PEEK Cranial Implant is a medical device manufactured by 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-04-04 under approval number K231834. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VSP PEEK Cranial Implant?
VSP PEEK Cranial Implant is a medical device that received FDA 510(k) clearance on 2024-04-04. It is manufactured by 3D Systems, Inc.. The 510(k) number is K231834.
When was VSP PEEK Cranial Implant approved by the FDA?
VSP PEEK Cranial Implant received FDA 510(k) clearance on 2024-04-04, under approval number K231834.
What company makes VSP PEEK Cranial Implant?
VSP PEEK Cranial Implant is manufactured by 3D Systems, Inc..
What is the FDA product code for VSP PEEK Cranial Implant?
The FDA product code for VSP PEEK Cranial Implant is GWO.
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Other Devices by 3D Systems, Inc.
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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.