FDA.report

510(k) K250711

Device
VSP Orthopedics System
Applicant
3D Systems, Inc.
510(k) number
K250711
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-05
Date received
2025-03-10
Regulation
888.3030
Classification name
Orthopaedic Surgical Planning And Instrument Guides
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ashley Dawson
Address
5381 S. Alkire Cir. Littleton CO US 80127 80127

FDA Registration Numbers

Source Documents

510(k) summary PDF

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