K243387
- 510(k) number
- K243387
- Device name
- GYDER® Hip System
- Applicant
- Gyder Surgical Pty, Ltd. AU
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-01-29
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243387.pdf
Official FDA record: K243387
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.