K243889 is an FDA 510(k) clearance for the Remplir (ON-152, 15 x 20 mm). This device is classified as a Cuff, Nerve (Class II - Special Controls, product code JXI).
Submitted by Orthocell, Ltd. (Murdoch, AU). The FDA issued a Cleared decision on April 2, 2025, 105 days after receiving the submission on December 18, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5275.
| 510(k) Number | K243889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2024 |
| Decision Date | April 02, 2025 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXI - Cuff, Nerve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5275 |