K201900 is an FDA 510(k) clearance for the 3D GraftRasp System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Surgentec (Boca Raton, US). The FDA issued a Cleared decision on September 3, 2020, 57 days after receiving the submission on July 8, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K201900 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2020 |
| Decision Date | September 03, 2020 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | FMF - Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |