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FDA 510(k)

VSP System

K-Number: K210347 · 2021-04-26

Applicant3D Systems
Decision Date2021-04-26
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VSP System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K210347. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSP System?

VSP System is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is 3D Systems. The 510(k) number is K210347.

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

VSP System received FDA 510(k) clearance on 2021-04-26, under 510(k) number K210347.

Who is the listed applicant for VSP System?

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

What is the FDA product code for VSP System?

The FDA product code for VSP System is DZJ.

Other records listing 3D Systems as applicant

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.

K261826VSP System (Titanium Palatal Splint)K250711VSP Orthopedics SystemK243174Cadence Ankle PSI SystemK243173Salto Talaris Ankle PSI SystemK241326Cadence Ankle PSI SystemK241148Salto Talaris Ankle PSI System

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Related Devices (Code: DZJ)

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.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcad

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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