K243888 is an FDA 510(k) clearance for the Medline UNITE® REFLEX® Hybrid Nitinol Implant System. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Medline Industries, LP (Northfield, US). The FDA issued a Cleared decision on April 11, 2025, 114 days after receiving the submission on December 18, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K243888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |