K221737 is an FDA 510(k) clearance for the InstaFill Graft Delivery System, SIGNIFY Bioactive. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on August 11, 2022, 57 days after receiving the submission on June 15, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K221737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2022 |
| Decision Date | August 11, 2022 |
| Days to Decision | 57 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 |