K230546
- 510(k) number
- K230546
- Device name
- SIGNEX
- Applicant
- Osteonic Co., Ltd. KR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-06-11
- Date received
- 2023-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230546.pdf
Official FDA record: K230546
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.