The following data is part of a premarket notification filed by 3d Systems, Inc. with the FDA for Vsp Orthopedics System.
| Device ID | K190044 |
| 510k Number | K190044 |
| Device Name: | VSP Orthopedics System |
| Classification | Orthopaedic Surgical Planning And Instrument Guides |
| Applicant | 3D Systems, Inc. 5381 South Alkire Circle Littleton, CO 80127 |
| Contact | Kim Torluemke |
| Correspondent | Kim Torluemke 3D Systems, Inc. 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 | 2019-01-09 |
| Decision Date | 2019-08-21 |