Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants— 510(k) K250713

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K250713 for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants, Substantially Equivalent on 2025-12-01. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2025-03-10
Decision date: 2025-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.