K243469
- 510(k) number
- K243469
- Device name
- SIGNEX
- Applicant
- Osteonic Co., Ltd. KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2025-05-29
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243469.pdf
Official FDA record: K243469
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.