510(k) K253592— Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

Substantially Equivalent

Zimmer, Inc.

Clearance details

Applicant: Zimmer, Inc.
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2025-11-17
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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.