K233254
- 510(k) number
- K233254
- Device name
- TELIGEN System Navigation Ready Instruments
- Applicant
- DePuy Synthes CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-06-14
- Date received
- 2023-09-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233254.pdf
Official FDA record: K233254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.