K233542
- 510(k) number
- K233542
- Device name
- Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
- Applicant
- Stryker Leibinger GmbH & Co KG DE
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-03-14
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233542.pdf
Official FDA record: K233542
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.