510(k) K231585
K231585 is an FDA 510(k) premarket notification submitted by 3D Systems, Inc. for the device "Vantage PSI System". The FDA issued a decision of Substantially Equivalent on June 30, 2023. The device falls under product code OYK (Ankle Arthroplasty Implantation System), a Class II device regulated under 21 CFR 888.3110. 3D Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2023
- Date Received
- May 31, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ankle Arthroplasty Implantation System
- Device Class
- Class II
- Regulation Number
- 888.3110
- Review Panel
- OR
- Submission Type
Intended to be used to assist in the implantation of a specific ankle arthroplasty device. Indicated to include guiding alignment, making or establishing cuts, and sizing.