K231516

Substantially Equivalent

INHANCE Shoulder System, Sterile Single Use Instrumentation

Applicant: Depuy Ireland UC
Product code: MBF
Advisory panel: Orthopedic
Date received: 2023-05-25
Decision date: 2023-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, IE

Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

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.