K260583
- 510(k) number
- K260583
- Device name
- Equinoxe® Shoulder System
- Applicant
- Exactech, Inc. FL · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2026-04-14
- Date received
- 2026-02-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260583.pdf
Official FDA record: K260583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.