The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for O-genesis Graft Delivery System.
| Device ID | K200606 |
| 510k Number | K200606 |
| Device Name: | O-Genesis Graft Delivery System |
| Classification | Syringe, Piston |
| Applicant | Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Contact | Troy Brooks |
| Correspondent | Troy Brooks Orthofix, Inc. 3451 Plano Parkway Lewisville, TX 75056 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2020-05-01 |