K243889
- 510(k) number
- K243889
- Device name
- Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
- Applicant
- Orthocell, Ltd. AU
- Product code
- JXI — Cuff, Nerve
- Decision date
- 2025-04-02
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K243889.pdf
Official FDA record: K243889
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.