K223745
- 510(k) number
- K223745
- Device name
- Novae® Dual Mobility System, Hype® Hip System
- Applicant
- Serf FR
- Product code
- LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol
- Decision date
- 2023-12-22
- Date received
- 2022-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K223745.pdf
Official FDA record: K223745
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.