The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Instafill Graft Delivery System, Signify Bioactive.
| Device ID | K221737 |
| 510k Number | K221737 |
| Device Name: | InstaFill Graft Delivery System, SIGNIFY Bioactive |
| Classification | Syringe, Piston |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-15 |
| Decision Date | 2022-08-11 |