K252418
- 510(k) number
- K252418
- Device name
- Catalyst F1x Shoulder System
- Applicant
- Catalyst Orthoscience, Inc. FL · US
- Product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2025-11-06
- Date received
- 2025-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252418.pdf
Official FDA record: K252418
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.