510(k) K212941— Porous Patella

Substantially Equivalent

Encore Medical, L.P. Dba Djo Surgical

Clearance details

Applicant: Encore Medical, L.P. Dba Djo Surgical
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2021-09-15
Decision date: 2022-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.