510(k) K162903— Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

Substantially Equivalent

Exactech, Inc.

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 2016-10-17
Decision date: 2017-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

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.