K243073
- 510(k) number
- K243073
- Device name
- AnyPlus Navigated Instruments System
- Applicant
- GS Medical Co., Ltd. KR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-12-06
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K243073.pdf
Official FDA record: K243073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.