Summit Patella Plating System— 510(k) K203408

Substantially Equivalent

Endeavor Orthopaedics, LLC

FDA 510(k) clearance K203408 for Summit Patella Plating System, Substantially Equivalent on 2021-07-30. Applicant: Endeavor Orthopaedics, LLC.

Clearance details

Applicant: Endeavor Orthopaedics, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-11-19
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.