K200606 is an FDA 510(k) clearance for the O-Genesis Graft Delivery System. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on May 1, 2020, 53 days after receiving the submission on March 9, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K200606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2020 |
| Decision Date | May 01, 2020 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |