K243456
- 510(k) number
- K243456
- Device name
- ONVOY Acetabular System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-06-06
- Date received
- 2024-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243456.pdf
Official FDA record: K243456
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.