K231649 is an FDA 510(k) clearance for the Intraosseous Fusion Device System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Auxano Medical, LLC (Brecksville, US). The FDA issued a Cleared decision on September 29, 2023, 115 days after receiving the submission on June 6, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K231649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2023 |
| Decision Date | September 29, 2023 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |