K233482
- 510(k) number
- K233482
- Device name
- Equinoxe® Central Screw Baseplate System
- Applicant
- Exactech, Inc. FL · US
- Product code
- PHX — Shoulder Prosthesis, Reverse Configuration
- Decision date
- 2024-07-18
- Date received
- 2023-10-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K233482.pdf
Official FDA record: K233482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.