K254043
- 510(k) number
- K254043
- Device name
- TRIVANCE Hip Stem
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2026-08-04
- Date received
- 2025-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254043.pdf
Official FDA record: K254043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.