K241082
- 510(k) number
- K241082
- Device name
- INNOVERSE Navigation Instruments
- Applicant
- Innosys Co., Ltd. KR
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-06-14
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241082.pdf
Official FDA record: K241082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.