K261410
- 510(k) number
- K261410
- Device name
- Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
- Applicant
- Suite 201, National Innovation Centre AU
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-07-30
- Date received
- 2026-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K261410.pdf
Official FDA record: K261410
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.