K252846
- 510(k) number
- K252846
- Device name
- TaperSet Hip System
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics CA · US
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2025-11-20
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252846.pdf
Official FDA record: K252846
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.