K250713
- 510(k) number
- K250713
- Device name
- Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- Applicant
- Exactech, Inc. FL · US
- Product code
- KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
- Decision date
- 2025-12-01
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K250713.pdf
Official FDA record: K250713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.