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FDA 510(k)

VSP Orthopedics System

K-Number: K190044 · 2019-08-21

Applicant3D Systems, Inc.
Decision Date2019-08-21
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VSP Orthopedics 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 2019-08-21 under 510(k) number K190044. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSP Orthopedics System?

VSP Orthopedics System is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is 3D Systems, Inc.. The 510(k) number is K190044.

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

VSP Orthopedics System received FDA 510(k) clearance on 2019-08-21, under 510(k) number K190044.

Who is the listed applicant for VSP Orthopedics 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 Orthopedics System?

The FDA product code for VSP Orthopedics System is PBF.

Other records listing 3D Systems, Inc. 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: PBF)

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.

K252064MedCAD® AccuStride™ SystemMedcadK250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcadK250394Fine TTO™Bodycad Laboratories, Inc.K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics

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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