K243888
- 510(k) number
- K243888
- Device name
- Medline UNITE® REFLEX® Hybrid Nitinol Implant System
- Applicant
- Medline Industries, LP IL · US
- Product code
- JDR — Staple, Fixation, Bone
- Decision date
- 2025-04-11
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243888.pdf
Official FDA record: K243888
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.