The following data is part of a premarket notification filed by 3d Systems with the FDA for Vsp® Orthopedics System.
Device ID | K211244 |
510k Number | K211244 |
Device Name: | VSP® Orthopedics System |
Classification | Orthopaedic Surgical Planning And Instrument Guides |
Applicant | 3D Systems 5381 South Alkire Circle Littleton, CO 80127 |
Contact | Ben Johnson |
Correspondent | Ben Johnson 3D Systems 5381 South Alkire Circle Littleton, CO 80127 |
Product Code | PBF |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-26 |
Decision Date | 2021-11-10 |