K252962
- 510(k) number
- K252962
- Device name
- DYNAMIS Navigation System
- Applicant
- Promethean Restorative, LLC CO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-01-12
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K252962.pdf
Official FDA record: K252962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.