K193432 is an FDA 510(k) clearance for the Vantage PSI System. This device is classified as a Ankle Arthroplasty Implantation System (Class II - Special Controls, product code OYK).
Submitted by 3D Systems (Littleton, US). The FDA issued a Cleared decision on November 9, 2020, 335 days after receiving the submission on December 10, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3110. 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..
| 510(k) Number | K193432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2019 |
| Decision Date | November 09, 2020 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OYK - Ankle Arthroplasty Implantation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3110 |
| Definition | 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. |