K243448
- 510(k) number
- K243448
- Device name
- Equinoxe® Shoulder System
- Applicant
- Exactech, Inc. FL · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2025-08-01
- Date received
- 2024-11-07
- 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: K243448.pdf
Official FDA record: K243448
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.