Identity Revision Humeral Stems— 510(k) K251098

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K251098 for Identity Revision Humeral Stems, Substantially Equivalent on 2025-08-11. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2025-04-10
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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.