K233368 is an FDA 510(k) clearance for the Allograft Delivery Device (OFAC-C). This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Bioventus, LLC (Durham, US). The FDA issued a Cleared decision on June 25, 2024, 267 days after receiving the submission on October 2, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K233368 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2023 |
| Decision Date | June 25, 2024 |
| Days to Decision | 267 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 |