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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-04-04 under 510(k) 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. The listed applicant is 3D Systems, Inc.. The 510(k) number is K231834.

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

VSP PEEK Cranial Implant received FDA 510(k) clearance on 2024-04-04, under 510(k) number K231834.

Who is the listed applicant for VSP PEEK Cranial Implant?

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 PEEK Cranial Implant?

The FDA product code for VSP PEEK Cranial Implant is GWO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05362370Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and EffectivenessACTIVE_NOT_RECRUITING

Other records listing 3D Systems, Inc. as applicant

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Related Devices (Code: GWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.K210360Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)Osteonic Co., Ltd.K203055Stryker PEEK Customized Cranial Implant KitStryker

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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