VSP® Orthopedics System

Orthopaedic Surgical Planning And Instrument Guides

3D Systems

The following data is part of a premarket notification filed by 3d Systems with the FDA for Vsp® Orthopedics System.

Pre-market Notification Details

Device IDK211244
510k NumberK211244
Device Name:VSP® Orthopedics System
ClassificationOrthopaedic Surgical Planning And Instrument Guides
Applicant 3D Systems 5381 South Alkire Circle Littleton,  CO  80127
ContactBen Johnson
CorrespondentBen Johnson
3D Systems 5381 South Alkire Circle Littleton,  CO  80127
Product CodePBF  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-11-10

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